|
NCT05283954
|
Use of a Combined Regimen of Fluoxetine, Prednisolone and Ivermectin in the Treatment of Mild COVID-19 to Prevent Disease Progression Progression in Papua New Guinea |
Not yet recruiting |
Phase 2|Phase 3 |
May/01/2022 |
Jul/30/2022 |
- Alternative id - Fluo-Pred-Iver
- Interventions - Drug: Combination regimen: Fluoxetine, Prednisolone, Ivermectin|Drug: Combination regimen: Albendazole, Vitamin C
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Treatment
- Enrollment - 954
- Age - 18 Years to 99 Years (Adult, Older Adult)
- Outcome measures - COVID-19 disease progression|SARS-CoV-2 viral load|COVID-19 WHO Clinical progression scale score|Adverse Events
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NCT05279482
|
Comparison Between Different Doses of Steroids in COVID-19 Patients |
Completed |
|
Jan/19/2022 |
Mar/09/2022 |
- Alternative id - MS41/2022
- Interventions - Other: observation for outcome of methylprednisolone dose
- Study type - Observational
- Study results - No Results Available
- Locations - Ain shams university hospitals, Cairo, Egypt|Faculty of medicine, Ain Shams University, Cairo, Egypt
- Study designs - Observational Model: Cohort|Time Perspective: Retrospective
- Enrollment - 104
- Age - Child, Adult, Older Adult
- Outcome measures - 28 days mortality rate|mechanical ventilation and icu length of stay
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NCT04636671
|
Methylprednisolone vs. Dexamethasone in COVID-19 Pneumonia (MEDEAS RCT) |
Recruiting |
Phase 3 |
Apr/14/2021 |
Oct/01/2021 |
- Alternative id - MEDEAS1
- Interventions - Drug: Methylprednisolone|Drug: Dexamethasone
- Study type - Interventional
- Study results - No Results Available
- Locations - Marco Confalonieri, Trieste, TS, Italy
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 680
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Survival|Reduction in the need for mechanical ventilation|Length of hospitalization|Need for tracheostomy|Reduction in systemic inflammation markers|Amelioration of oxygenation|Disease progression
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NCT04847687
|
Investigation of Hospitalisation Times and Mortality According to Drug Dose in Patients Given Systemic Methylprednisolone With a Pre-diagnosis of Covid-19 Pneumonia; Retrospective Study |
Completed |
|
Mar/01/2021 |
Apr/01/2021 |
- Alternative id - 2011-KAEK-25 2021/03-02
- Interventions - Drug: methylprednisolone
- Study type - Observational
- Study results - No Results Available
- Locations - Bursa Yüksek İhtisas EAH, Bursa, Eyalet/Yerleşke, Turkey
- Study designs - Observational Model: Other|Time Perspective: Retrospective
- Enrollment - 300
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - prognosis|hospitalization time
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NCT04559113
|
Methylprednisolone in COVID-19 Patients (Methyl19LGH) |
Recruiting |
Not Applicable |
May/01/2020 |
Dec/30/2020 |
- Alternative id - LGH005
- Interventions - Drug: Methylprednisolone Injectable Product
- Study type - Interventional
- Study results - No Results Available
- Locations - Muhammad Irfan Malik, Lahore, Punjab, Pakistan
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 200
- Age - 18 Years to 80 Years (Adult, Older Adult)
- Outcome measures - Clinical response after administration|Clinical response to treatment|Duration of hospitalization
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NCT05133635
|
High-Dose Corticosteroid or Tocilizumab for Clinical Worsening of COVID-19 |
Withdrawn |
Phase 4 |
Feb/01/2021 |
Apr/01/2021 |
- Alternative id - Steroid/Toci COVID-19
- Interventions - Drug: Methylprednisolone|Drug: Tocilizumab
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Supportive Care
- Enrollment - 0
- Age - 18 Years to 70 Years (Adult, Older Adult)
- Outcome measures - Clinical condition|Blood analysis|Hospital stay|Mortality
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NCT04657484
|
Comparison of Two Corticosteroid Regimens for Post COVID-19 Diffuse Lung Disease |
Recruiting |
Not Applicable |
Dec/08/2020 |
Dec/07/2021 |
- Alternative id - INT/IEC/2020/SPL-1528
- Interventions - Drug: Medium dose prednisolone|Drug: Low dose prednisolone
- Study type - Interventional
- Study results - No Results Available
- Locations - Postgraduate Institute of Medical Education and Research, Chandigarh, India
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 100
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Proportion of subjects with a complete radiologic response|Proportion of subjects with a complete or good response radiologic response|Proportion of subjects with a good composite response|Forced vital capacity as a percentage of the predicted|Change in resting oxygen saturation|Proportion of subjects with oxygen desaturation on exercise testing|Change in dyspnea score on modified Medical Research Council scale|Severity of dyspnea on the Functional Assessment of Chronic Illness Therapy - Dyspnea-10 item scale|Change in respiratory health status using the King's Brief ILD questionnaire|Change in health-related quality of life using the Short Form-36 questionnaire|Proportion of subjects who develop adverse effects of prednisolone
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NCT04603729
|
Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease |
Completed |
Phase 3 |
May/30/2020 |
Jul/01/2020 |
- Alternative id - FMH-06-2020-IRB-763-M
- Interventions - Drug: Dexamethasone 2 MG/ML|Drug: Methylprednisolone Injection
- Study type - Interventional
- Study results - No Results Available
- Locations - Fatima Memorial Hospital, Lahore, Punjab, Pakistan
- Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 100
- Age - 18 Years to 75 Years (Adult, Older Adult)
- Outcome measures - temperature (F)|oxygen saturation(%)|CRP (mg/dl)|mortality|ICU transfer
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NCT04341038
|
Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With COVID-19 Lung Injury |
Recruiting |
Phase 3 |
Apr/01/2020 |
Jul/01/2020 |
- Alternative id - TACRO-BELL-COVID|2020-001445-39
- Interventions - Drug: Tacrolimus|Drug: Methylprednisolone
- Study type - Interventional
- Study results - No Results Available
- Locations - Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 84
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Time to reach clinical stability|Time to reach an afebrile state for 48 hours.|Time to reach PaO2 / FiO2> 400 and / or SatO2 / FiO2> 300|Time to reach FR ≤ 24 rpm for 48 hours|Time to normalization of D-dimer (<250 ug / L)|Time until PCR normalization (<5mg / L).|Time until normalization of ferritin (<400ug / L)|Study the impact of immunosuppressive treatment on viral load using quantitative PCR|Time until hospital discharge|Need for ventilatory support devices|Duration that it is necessary to maintain ventilatory support.|COVID-19 mortality|all-cause mortality|Analyze the expanded cytokine profile before the start of treatment and their evolution every 7 days after admission|Describe the side effects and their severity attributed to tacrolimus and / or methylprednisolone.
|
|
NCT04374071
|
Early Short Course Corticosteroids in COVID-19 |
Completed |
|
Mar/12/2020 |
Apr/30/2020 |
- Alternative id - HFH IRB # 13739
- Interventions - Drug: Methylprednisolone
- Study type - Observational
- Study results - No Results Available
- Locations - Henry Ford Hospital, Detroit, Michigan, United States
- Study designs - Observational Model: Cohort|Time Perspective: Retrospective
- Enrollment - 250
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Transfer to Intensive care unit (ICU)|Need for Mechanical Ventilation|Mortality|Development and Severity of ARDS|Length of hospital stay (LOS).
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NCT05002517
|
Randomized, Unicentric, Open, Controlled Clinical Trial, in Phase Iii, to Demonstrate the Effectiveness of Tocilizumab |
Active, not recruiting |
Phase 3 |
Sep/03/2020 |
Oct/31/2021 |
- Alternative id - TOCICOVID
- Interventions - Drug: Tociliziumab group|Drug: Methylprednisolone group
- Study type - Interventional
- Study results - No Results Available
- Locations - Clinical Research Platform Biodonostia Health Research Institute, San Sebastián, Guipuzcoa, Spain
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 60
- Age - 18 Years to 99 Years (Adult, Older Adult)
- Outcome measures - Respiratory situation at 24 hours, 3 and 7 days based on the PaO2 / FiO2 ratio that graduates respiratory distress into mild (200-300), moderate (100-200) and severe (<100).|Immune hyperactivation situation: LDH, D-dimer and ferritin value at 24 hours, 3 and 7 days. Each one is a quantitative variable.|Mechanical ventilation: qualitative variable (yes or no)|Combined variable of variables i, iii and in-hospital mortality (this is understood to be: respiratory deterioration or need for mechanical ventilation or in-hospital death)|Number of patients admitted to the ICU|Time to admission to the ICU (from the beginning of the trial and from the beginning of the picture)|Time to the start of mechanical ventilation (from the start of the trial and from the start of the picture)|Time of admission to ICU|Total admission time|In-hospital mortality|Mortality at 30 and 60 days|Respiratory situation at 30 and 60 days according to pulse oximetric O2 saturation, respiratory rate and presence of dyspnea and NYHA grade.|Documented nosocomial infections
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NCT04349410
|
The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol |
Completed |
Phase 2|Phase 3 |
Apr/11/2020 |
Sep/14/2020 |
- Alternative id - FMTVDM2020
- Interventions - Drug: Hydroxychloroquine, Azithromycin|Drug: Hydroxychloroquine, Doxycycline|Drug: Hydroxychloroquine, Clindamycin|Drug: Hydroxychloroquine, Clindamycin, Primaquine - low dose.|Drug: Hydroxychloroquine, Clindamycin, Primaquine - high dose.|Drug: Remdesivir|Drug: Tocilizumab|Drug: Methylprednisolone|Drug: Interferon-Alpha2B|Drug: Losartan|Drug: Convalescent Serum
- Study type - Interventional
- Study results - No Results Available
- Locations - FHHI-OI-Camelot; QME, Los Angeles, California, United States
- Study designs - Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: Single (Investigator)|Primary Purpose: Treatment
- Enrollment - 1800
- Age - Child, Adult, Older Adult
- Outcome measures - Improvement in FMTVDM Measurement with nuclear imaging.|Ventilator status|Survival status
|
|
NCT05047874
|
High-dose, Short-term Steroid and Low-dose Long-term Steroid Use in ARDS Caused by COVID-19 |
Recruiting |
|
Sep/20/2021 |
Oct/30/2021 |
- Alternative id - BIRUNI 1
- Interventions - Behavioral: systemic methylprednisolone
- Study type - Observational
- Study results - No Results Available
- Locations - Ilke Kupeli, Istanbul, Turkey
- Study designs - Observational Model: Cohort|Time Perspective: Retrospective
- Enrollment - 200
- Age - 18 Years to 105 Years (Adult, Older Adult)
- Outcome measures - C Reaktif Protein
|
|
NCT04323592
|
Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome |
Completed |
|
Mar/23/2020 |
May/10/2020 |
- Alternative id - MP-19 023_2020
- Interventions - Drug: Methylprednisolone|Other: standard care
- Study type - Observational
- Study results - Has Results
- Locations - Marco Confalonieri, Trieste, TS, Italy
- Study designs - Observational Model: Cohort|Time Perspective: Prospective
- Enrollment - 173
- Age - 18 Years to 80 Years (Adult, Older Adult)
- Outcome measures - Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28|In-hospital Death Within 28 Days|Admission to Intensive Care Unit (ICU)|Endotracheal Intubation (Invasive Mechanical Ventilation)|Change in C-reactive Protein (CRP)|Number of Days Free From Mechanical Ventilation
|
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NCT04377503
|
Tocilizumab Versus Methylprednisolone in the Cytokine Release Syndrome of Patients With COVID-19 |
Not yet recruiting |
Phase 2 |
May/01/2020 |
Nov/01/2020 |
- Alternative id - covid-19 hsd
- Interventions - Drug: Tocilizumab 180 MG/ML|Drug: Methylprednisolone Sodium Succinate
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 40
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Patient clinical status 15 days after randomization|Improving oxygenation|Thorax CT improvement|ICU length of stay|Duration of mechanical ventilation|Incidence of acute kidney (AKI) with necessity of renal replacement therapy
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NCT04263402
|
The Efficacy of Different Hormone Doses in 2019-nCoV Severe Pneumonia |
Unknown status |
Phase 4 |
Feb/01/2020 |
Jul/01/2020 |
- Alternative id - TJ20200201
- Interventions - Drug: Methylprednisolone
- Study type - Interventional
- Study results - No Results Available
- Locations - Department and Institute of Infectious Disease, Wuhan, Hubei, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
- Enrollment - 100
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Rate of disease remission|Rate and time of entering the critical stage|Rate of normal tempreture|Rate of respiratory symptom remission|Rate of lung imaging recovery|Rate of laboratory indicator recovery|Rate of undetectable viral RNA
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NCT04438980
|
Glucocorticoids in COVID-19 (CORTIVID) |
Completed |
Phase 3 |
May/15/2020 |
Apr/09/2021 |
- Alternative id - CORTIVID
- Interventions - Drug: Methylprednisolone|Other: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Hospital Sant Joan Despí Moisès Broggi, Sant Joan Despí, Barcelona, Spain|Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 72
- Age - 18 Years to 75 Years (Adult, Older Adult)
- Outcome measures - Proportion of patients developing treatment failure|Mortality at day 28|Proportion of patients requiring ICU admission|Proportion of patients requiring rescue-therapy with tocilizumab|Length of hospital stay|Proportion of severe adverse events|Proportion of bacterial, fungal or opportunistic infections|Evolution of inflammatory biomarkers related to COVID-19|Proportion of SARS-CoV-2 clearance.
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NCT05062681
|
RCT on the Efficacy of Dexamethasone Versus Methyl Prednisolone in Covid-19 Infected Patients With High Oxygen Flow |
Recruiting |
Phase 4 |
Sep/15/2021 |
Mar/15/2022 |
- Alternative id - Steroids in COVID-19
- Interventions - Drug: Dexamethasone|Drug: Methylprednisolone
- Study type - Interventional
- Study results - No Results Available
- Locations - Eman Osama, Cairo, Egypt
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
- Enrollment - 60
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - 28 days in hospital mortality|WHO clinical progression scale|Adverse events related to steroids|Duration of ICU stay|Duration of high oxygen supplementation
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NCT04273321
|
Efficacy and Safety of Corticosteroids in COVID-19 |
Completed |
Not Applicable |
Feb/14/2020 |
Apr/15/2020 |
- Alternative id - Methylprednisolone in COVID-19
- Interventions - Drug: Methylprednisolone
- Study type - Interventional
- Study results - No Results Available
- Locations - Hubei province hospital of integrated Chinese & Western Medicine, Wuhan, Hubei, China|Yichang first people's Hospital, Yichang, Hubei, China|Beijing YouAn Hospital, Beijing, China|Renmin Hospital of Wuhan University, Wuhan, China|Tianyou Hospital Affiliated to Wuhan University of science and technology, Wuhan, China|Union Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology, Wuhan, China|the first peopel hospital of Xiangyang, Xiangyang, China
- Study designs - Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 86
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - the incidence of treatment failure in 14 days|clinical cure incidence in 14 days|the duration of virus change to negative|mortality at day 30|ICU admission rate in 30 days
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NCT04343729
|
Methylprednisolone in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome in Covid-19 |
Completed |
Phase 2 |
Apr/18/2020 |
Oct/20/2020 |
- Alternative id - CAEE: 30615920.2.0000.0005
- Interventions - Drug: Methylprednisolone Sodium Succinate|Drug: Placebo solution
- Study type - Interventional
- Study results - No Results Available
- Locations - Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz, Manaus, Amazonas, Brazil
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 416
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Mortality rate at day 28|Mortality rate on days 7, 14 and 28|Incidence of orotracheal intubation|Change in oxygenation index
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NCT04988282
|
Systemic Corticosteroids in Treatment of Post-COVID-19 Interstitial Lung Disease |
Recruiting |
Phase 4 |
May/24/2021 |
Dec/31/2021 |
- Alternative id - STERCOV-ILD
- Interventions - Drug: Methylprednisolone Tablet
- Study type - Interventional
- Study results - No Results Available
- Locations - Ufuk University Medicine Faculty, Ankara, Turkey
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 642
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - % of patients with good clinical response|Radiological improvement|Improvement of diffusion capacity of lung for carbon monoxide (DLCO)|Improvement of Forced Vital Capacity (FVC)|Improvement of arterial oxygen saturation (SaO2)|Improvement of Exercise Capacity
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NCT04673162
|
Evaluation of the Efficacy of High Doses of Methylprednisolone in SARS-CoV2 ( COVID-19) Pneumonia Patients |
Not yet recruiting |
Phase 3 |
Dec/01/2020 |
Jun/01/2021 |
- Alternative id - RCT-MP-COVID-19
- Interventions - Drug: Methylprednisolone, Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - SOC Pneumologia, SOC Malattie Infettive, SOC Reumatologia, Az USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 260
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Length of hospitalization
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NCT04528888
|
Steroids and Unfractionated Heparin in Critically Ill Patients With Pneumonia From COVID-19 Infection |
Recruiting |
Phase 3 |
Nov/25/2020 |
Jul/30/2021 |
- Alternative id - Staunch-19-1.1-26-04-20
- Interventions - Drug: Enoxaparin|Drug: Methylprednisolone|Drug: unfractionated heparin
- Study type - Interventional
- Study results - No Results Available
- Locations - ICU- University Hospital Modena, Modena, Italy
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 210
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - All-cause mortality at day 28|All-cause mortality at ICU discharge|All-cause mortality at hospital discharge|Need of rescue administration of high-dose steroids or immune-modulatory drugs|New organ dysfunction during ICU stay|Grade of organ dysfunction during ICU stay|ICU free days at day 28|Occurrence of new infections|Ventilation free days at day 28|Vasopressors free-days at day 28|Switch from non-invasive to invasive mechanical ventilation|Delay from start of non-invasive ventilation to switch to invasive ventilation|Occurrence of protocol related adverse events|Occurrence of venous thromboembolism, stroke or myocardial infarction|Occurrence of major bleeding (safety end point)|Occurrence of clinically relevant non-major bleeding (safety end point)
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NCT04355247
|
Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm |
Recruiting |
Phase 2 |
Apr/14/2020 |
Apr/30/2021 |
- Alternative id - CCAM 20-01
- Interventions - Drug: MethylPREDNISolone 80 Mg/mL Injectable Suspension
- Study type - Interventional
- Study results - No Results Available
- Locations - San Juan City Hospital / Puerto Rico Medical Center, San Juan, Puerto Rico|Hospital Auxilio Mutuo Cancer Center, San Juan, Puerto Rico
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 20
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Clinical complete response criteria|Clinical Partial Response criteria|Secondary response criteria
|
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NCT04499313
|
Dexamethasone Vs Methylprednisolone for the Treatment of Patients With ARDS Caused by COVID-19 |
Recruiting |
Phase 3 |
Aug/02/2020 |
Nov/30/2020 |
- Alternative id - 10000753
- Interventions - Drug: Dexamethasone|Drug: Methylprednisolone
- Study type - Interventional
- Study results - No Results Available
- Locations - Chattogram General Hospital, Chittagong, Bangladesh|M. Abdur Rahim Medical College Hospital, Dinajpur, Bangladesh
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 60
- Age - 20 Years to 80 Years (Adult, Older Adult)
- Outcome measures - Mortality rate (In hospital)|Clinical improvement|Ventilator free days|Changes in Oxygen level
|
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NCT04485429
|
Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia |
Withdrawn |
Phase 3 |
Jul/20/2020 |
Dec/31/2022 |
- Alternative id - 31180820600005249
- Interventions - Drug: Methylprednisolone|Drug: Heparin
- Study type - Interventional
- Study results - No Results Available
- Locations - D'Or Institute for Research and Education, Rio de Janeiro, Brazil
- Study designs - Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 0
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Rate of invasive mechanical ventilation|Severity assessment by ordinal severity scale|Severity assessment by SOFA score|Length of hospital stay|Length of stay in intensive care|Death rate
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NCT04244591
|
Glucocorticoid Therapy for COVID-19 Critically Ill Patients With Severe Acute Respiratory Failure |
Completed |
Phase 2|Phase 3 |
Jan/26/2020 |
Apr/13/2020 |
- Alternative id - Glucocorticoid COVID-19
- Interventions - Drug: methylprednisolone therapy|Other: Standard care
- Study type - Interventional
- Study results - No Results Available
- Locations - Medical ICU,Peking Union Medical College Hospital, Beijing, Beijing, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 80
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Lower Murray lung injury score|The difference of PaO2/FiO2 between two groups|Lower Sequential Organ Failure Assessment (SOFA) score|Mechanical ventilation support|Clearance of noval coronavirus|All-cause mortality
|
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NCT04826588
|
Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY) |
Recruiting |
Phase 3 |
May/23/2021 |
Jul/01/2022 |
- Alternative id - 2021-00362; ks21Bielicki2
- Interventions - Drug: Methylprednisolone sodium succinate 10 mg/kg intravenously|Biological: Human normal immunoglobulin (IVIg)|Drug: Methylprednisolone sodium succinate 2 mg/kg
- Study type - Interventional
- Study results - No Results Available
- Locations - Cantonal Hospital Aarau, Department of Paediatrics, Aarau, Switzerland|University of Basel Children's Hospital, Basel, Switzerland|Ente Ospedaliero Cantonale Ticino (EOC) Pediatrica, Bellinzona, Switzerland|Department of Pediatrics, University of Bern, Bern, Switzerland|Department of Child, Woman and, Adolescent Medecine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland|Department of Pediatrics,University Hospital of Lausanne (CHUV), Lausanne, Switzerland|Department of Pediatrics, Cantonal Hospital Luzern, Luzern 16, Switzerland|Children's Hospital of Eastern Switzerland, St. Gallen, Switzerland|Department of Pediatrics, Cantonal Hospital Fribourg, Villars-sur-Glâne, Switzerland|University Children's Hospital Zuerich, Zuerich, Switzerland
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 75
- Age - 44 Weeks to 18 Years (Child, Adult)
- Outcome measures - Hospital length of stay|All-cause mortality among patients|Composite endpoint of death or need for mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
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NCT04329650
|
Efficacy and Safety of Siltuximab vs. Corticosteroids in Hospitalized Patients With COVID-19 Pneumonia |
Recruiting |
Phase 2 |
Apr/15/2020 |
May/20/2020 |
- Alternative id - SILCOR-COVID-19
- Interventions - Drug: Siltuximab|Drug: Methylprednisolone
- Study type - Interventional
- Study results - No Results Available
- Locations - Hospital Germans Trias i Pujol, Badalona, Spain|Hospital Clínic de Barcelona, Barcelona, Spain|Hospital Universitario de Salamanca, Salamanca, Spain|Hospital Universitari Mútua de Terrassa, Terrassa, Spain
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 200
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Proportion of patients requiring ICU admission at any time within the study period.|Days of stay in the ICU during the study period.|Days until resolution of fever defined as body temperature (axillary ≤ 36.6 ° C, oral ≤ 37.2 ° C, or rectal or tympanic ≤ 37.8 ° C) for at least 48 hours, without administration of antipyretics or until hospital discharge.|Proportion of patients with a worsening requirement of supplemental oxygen at 29 days. days.|Days with hypoxemia (SpO2 <93% in ambient air or requiring oxygen supplemental or mechanical ventilation support) at 29 days.|Proportion of patients using mechanical ventilation at 29 days.|Days with use of mechanical ventilation at 29 days.|Days until the start of use of mechanical ventilation, non-invasive ventilation or use of high flow nasal cannula (if the patient have not previously required these interventions at the inclusion of the study) at 29 days.|Days of hospitalization among survivors at 29 days.|Mortality rate from any cause at 29 days.|Proportion of patients with serious adverse events at 29 days.|Proportion of patients with invasive bacterial or fungal infections clinically significant or opportunistic with grade 4 neutropenia (count neutrophil absolute <500 / mm3) at 29 days.|Proportion of patients with invasive bacterial or fungal infections clinically significant or opportunistic at 29 days.|Proportion of patients with grade 2 or higher adverse reactions related to the infusion of the sudy treatments at 29 days.|Proportion of patients with hypersensitivity reactions of grade 2 or higher related to the administration of the study treatments at 29 days.|Proportion of patients with gastrointestinal perforation at 29 days.|Proportion of patients with secondary severe infections confirmed by laboratory or worsening of existing infections at 29 days.|Changes from baseline in plasma leukocyte levels at days 1, 3, 5, 7 and 9.|Changes from baseline in plasma hemoglobin levels at days 1, 3, 5, 7 and 9.|Changes from baseline in plasma platelet at days 1, 3, 5, 7 and 9.|Changes from baseline in plasma creatinine levels at days 1, 3, 5, 7 and 9.|Changes from baseline in plasma total bilirubin levels at days 1, 3, 5, 7 and 9.|Proportion of patients with ALT≥ 3 times ULN (for patients with initial values normal) or> 3 times ULN AND at least 2 times more than the initial value (for patients with abnormal initial values) at days 1, 3, 5, 7 and 9.|Changes from baseline in plasma biomarkers (PCR, lymphocytes, ferritin, d-dimer and LDH) at days 1, 3, 5, 7 and 9.|Changes from baseline in chest Rx at days 1, 3 and 5.
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NCT04909918
|
Impact of Steroids on Inflammatory Response in Covid-19 |
Completed |
Phase 3 |
May/28/2021 |
Aug/20/2021 |
- Alternative id - 17300610
- Interventions - Drug: Dexamethasone|Drug: Methylprednisolone
- Study type - Interventional
- Study results - No Results Available
- Locations - Assiut university hospital, Assiut, Assuit, Egypt
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Treatment
- Enrollment - 60
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Neutrophil/lymphocyte ratio (NLR)|Interleukin-6 (IL-6) level|C-reactive protein (CRP) test|Arterial oxygen tension/ inspired oxygen fraction (P/F ratio)|ICU stay|ICU mortality
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NCT03852537
|
Steroid Dosing by bioMARker Guided Titration in Critically Ill Patients With Pneumonia |
Completed |
Phase 2 |
Dec/02/2019 |
Nov/17/2020 |
- Alternative id - 18-010925
- Interventions - Drug: Methylprednisolone|Other: Usual Care
- Study type - Interventional
- Study results - Has Results
- Locations - Mayo Clinic in Rochester, Rochester, Minnesota, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
- Enrollment - 44
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Timely Initiation of Corticosteroids and Implementation of Biomarker-titrated Corticosteroid Dosing|Mortality|Need for High Flow Nasal Cannula Oxygen|Need for Noninvasive Mechanical Ventilation|Need for Invasive Mechanical Ventilation|Organ Failure|New Onset Cardiac Arrhythmias|Myocardial Injury|Cardiovascular Dysfunction|Occurrence of Hyperglycemia|Occurrence of Delirium|Occurrence of Secondary Infection|ICU Admission|Oxygen-free Days
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NCT04780581
|
Glucocorticoid Therapy in Coronavirus Disease COVID-19 Patients |
Recruiting |
Phase 4 |
Feb/01/2021 |
Dec/31/2021 |
- Alternative id - MP3-pulses-COVID-19
- Interventions - Drug: Dexamethasone|Drug: Methylprednisolone
- Study type - Interventional
- Study results - No Results Available
- Locations - Complejo Asistencial Universitario de Burgos, Burgos, Spain|Complejo Asistencial Universitario de León, León, Spain|Complejo Asistencial Universitario de Salamanca, Salamanca, Spain|Hospital Clínico Universitario de Valladolid, Valladolid, Spain|Hospital Universitario Río Hortega, Valladolid, Spain
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 290
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Mortality rate in COVID-19 patients after high-dose methylprednisolone bolus administration versus mortality rate intermediate-dose dexamethasone pattern (RECOVERY trial)|Admission in Intensive Unit Care (ICU)|Evaluation of respiratory support requirements|Days in hospital|Evaluation of presence of adverse events related with use of high dose of glucocorticoids.|Evaluation of other immunosuppressors requirements.|Status according to the World Health Organization (WHO) 10-category scale.
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NCT04765371
|
Comparison Between Prednisolone and Dexamethasone on Mortality in Patients on Oxygen Therapy, With CoViD-19 |
Recruiting |
Phase 3 |
Mar/03/2021 |
Oct/01/2023 |
- Alternative id - CHRD1520|2020-005883-78
- Interventions - Drug: DEXAMETHASONE|Drug: PREDNISOLONE
- Study type - Interventional
- Study results - No Results Available
- Locations - Department of Emergency, Hospital Victor Dupouy, Argenteuil, France|Department of Pneumology and Infectious Medicine, Hospital Carnelle Portes de l'Oise, Beaumont, France|Department of Infectious and Tropical Diseases, Hospital Simone Veil, Eaubonne, France|Department of Infectious Medicine, Hospital of Gonesse, Gonesse, France|Department of Internal Medicine, Hospital Emile Roux - Le Puy-en-Velay, Le Puy-en-Velay, France|Department of Infectious and Tropical Diseases, Hospital René Dubos,, Pontoise, France|Department of Infectious and respiratory Diseases, Hospital Delafontaine, Saint-Denis, France|Department of Pneumology and Infectious Diseases, Hospital of Saint-Quentin, Saint-Quentin, France
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 220
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Mortality assessment at D28|Assessment of clinical course in both groups (arms)|Measurement of evolution of respiratory symptoms in both groups (arms)|Assessment of patient satisfaction towards the treatment|Comparison betwween D1 and D28 of patient quality of life evolution between randomization groups (arms)|Comparison betwween D1 and D28 of adverse events and adverse effects between randomization groups (arms)
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NCT04345445
|
Study to Evaluate the Efficacy and Safety of Tocilizumab Versus Corticosteroids in Hospitalised COVID-19 Patients With High Risk of Progression |
Not yet recruiting |
Phase 3 |
Apr/15/2020 |
Oct/31/2020 |
- Alternative id - TVCS-COVID19
- Interventions - Drug: Tocilizumab|Drug: Methylprednisolone
- Study type - Interventional
- Study results - No Results Available
- Locations - University Malaya Medical Centre, Kuala Lumpur, Malaysia
- Study designs - Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 310
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - The proportion of patients requiring mechanical ventilation|Mean days of ventilation|The proportion of patients requiring ICU admission|Overall 28-day survival|Change in symptom severity assessed by the World Health Organization (WHO) Coronavirus Disease 2019 (COVID19) ordinal scale measured daily up to 7 days from baseline|Duration of hospital and ICU stay
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NCT03708718
|
Prednisolone in Early Diffuse Systemic Sclerosis |
Completed |
Phase 2 |
Dec/21/2017 |
May/27/2021 |
- Alternative id - 119220
- Interventions - Drug: Prednisolone 5 mg|Drug: Placebo oral capsule; From August 2020 'no additional treatment'
- Study type - Interventional
- Study results - No Results Available
- Locations - Aberdeen Royal Infirmary - NHS Grampian, Aberdeen, Aberdeenshire, United Kingdom|Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust, Cambridge, Cambridgeshire, United Kingdom|Salford Royal NHS Foundation Trust, Salford, Greater Manchester, United Kingdom|Glasgow Royal Infirmary -, Glasgow, Lanarkshire, United Kingdom|Aintree University Hospitals NHS Foundation Trust, Liverpool, Merseyside, United Kingdom|Queen's Medical Centre - Nottingham University Hospitals NHS Trust, Nottingham, Nottinghamshire, United Kingdom|Royal National Hospital For Rheumatic Diseases - Royal United Hospitals Bath NHS Foundation Trust, Bath, Somerset, United Kingdom|Royal Hallamshire Hospital - Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, South Yorkshire, United Kingdom|Freeman Hospital - The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, Tyne And Wear, United Kingdom|The Dudley Group NHS Foundation Trust, Dudley, West Midlands, United Kingdom|Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, West Yorkshire, United Kingdom|Southmead Hospital Bristol - North Bristol NHS Trust, Bristol, United Kingdom|Ninewells Hospital and Medical School - NHS Tayside, Dundee, United Kingdom|Royal Free London NHS Foundation Trust, London, United Kingdom
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 35
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Health Assessment Questionnaire Disability Index (HAQ-DI)|modified Rodnan Skin Score (mRSS)|Quality of life and functional ability - Assessed by Questionnaire|Pain and disability|Functional ability - Assessed by Questionnaire|Pain associated with itch - Assessed by Questionnaire|Hand function - Assessed by Questionnaire|Fatigue - Assessed by Questionnaire|Anxiety and depression - Assessed by questionnaire|Health related quality of life - Assessed by Questionnaire|Health related quality of Life - Assessed by Questionnaire|Assessment of pain - Clinician assessment|Pain and disability - Assessed by Questionnaire
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