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NCT05003492
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Utilizing the Crosstalk Among Aerosolized Phenformin , Methylene Blue, Photodynamic Therapy , Zinc and Potassium for Treating Severe COVID-19 Infection and Its Inflammatory Complication |
Not yet recruiting |
Phase 1|Phase 2 |
Sep/01/2021 |
Nov/01/2021 |
- Alternative id - Novel treatment of COVID-19
- Interventions - Combination Product: Combination therapy plus Standard therapy|Radiation: Photodynamic therapy|Drug: Standard therapy
- Study type - Interventional
- Study results - No Results Available
- Locations - Ministry of health.First health cluster ,Riaydh, Riyadh, Saudi Arabia
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 2
- Age - 18 Years to 70 Years (Adult, Older Adult)
- Outcome measures - lung injury score|Serum levels of IL-6,TNF,TLR3,CRP, ESR and Type I interferon|Serum level of COVID19 RNA|All cause mortality rate|Ventilation free days|ICU free days|D-dimers less than 250 ng/mL, or less than 0.4 mcg/mL of blood sample|Time to first negative SARS-CoV-2 PCR in NP swap|Angiotensin 1-7 (Ang 1-7) changes over time|Angiotensin 1-5 (Ang 1-5) changes over time|Renin changes over time|Aldosterone changes over time|Angiotensin-converting enzyme II (ACE2) changes over time|Frequency of adverse events and severe adverse events|Angiotensin II (Ang II) changes over time|Sequential organ failure assessment score(SOFA score) over time and 14 ]|Thrombin time (TT)|Comparison of oxygen saturation dynamics measured by pulse oximeter before and after treatment
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NCT04547127
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A Study to Evaluate Safety and Efficacy of Convalescent Methylene Blue Treated (MBT) Plasma From Donors Recovered From Coronavirus Disease 2019 (COVID-19) |
Completed |
Phase 2 |
Apr/29/2020 |
Feb/04/2021 |
- Alternative id - GC2003|2020-001299-14
- Interventions - Biological: Convalescent anti-SARS-CoV-2 MBT Plasma|Drug: Standard Medical Treatment
- Study type - Interventional
- Study results - No Results Available
- Locations - Hospital General Universitario de Alicante, Alicante, Spain|Hospital Universitari Vall d'Hebron, Barcelona, Spain|Hospital Universitari de Girona Doctor Josep Trueta, Girona, Spain|Hospital Universitari de Bellvitge, L'Hospitalet De Llobregat, Spain|Hospital Universitari Arnau de Vilanova, Lleida, Spain|Fundación Jimenez Diaz, Madrid, Spain|Hospital Clínico San Carlos, Madrid, Spain|Hospital Universitario La Paz, Madrid, Spain|Hospital Universitario La Princesa, Madrid, Spain|Complejo Hospitalario Universitario de Canarias, Santa Cruz De Tenerife, Spain|Hospital Clínico Universitario de Santiago -CHUS, Santiago, Spain|Hospital Universitari Joan XXIII, Tarragona, 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 - All-Cause Mortality Rate|Change from Baseline in National Early Warning Score (NEWS)|Time to Clinical Response as Assessed by NEWS ≤ 2 Maintained for 24 hours|Time to Hospital Discharge|Time to ICU Discharge|Duration of All Oxygen Use|Duration of Mechanical Ventilation|Absolute Value Change from Baseline in Ordinal Scale|Mean Change from Baseline in Ordinal Scale|Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
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NCT04376788
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Exchange Transfusion Versus Plasma From Convalescent Patients With Methylene Blue in Patients With COVID-19 |
Recruiting |
Phase 2 |
May/20/2020 |
Sep/01/2020 |
- Alternative id - FMASU P22/2020
- Interventions - Biological: exchange blood transfusion from normal donor|Biological: plasma from convalescent patients with COVID-19|Drug: Methylene Blue 5 MG/ML
- Study type - Interventional
- Study results - No Results Available
- Locations - Ain Shams University, Cairo, Egypt
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 15
- Age - 18 Years to 65 Years (Adult, Older Adult)
- Outcome measures - improvement of condition|change in organs function with PFS and OS
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NCT04619290
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Outpatient Treatment With CoVid-19 With Prexablu |
Recruiting |
Phase 1 |
Oct/12/2020 |
Dec/30/2020 |
- Alternative id - 064.I.2020
- Interventions - Drug: Sublingual Methylene blue|Other: Control patients
- Study type - Interventional
- Study results - No Results Available
- Locations - Hospital Regional Lic Adolfo Lopez Mateos, Mexico City, Ciudad De Mexico CDMX (Mexico City), Mexico
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 46
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Change form baseline in Arterial oxygen saturation|Days to clinical improvement|Change Form Baseline in C reactive protein at 7 days|Change Form Baseline in IL-1β|Change Form Baseline in Erythrocyte sedimentation rate like procalcitonin|Change Form Baseline in Ferritin levels|Change Form Baseline in D dimer
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NCT04933864
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COVID-19 Treatment Using Methylene Blue and Photodynamic Therapy |
Completed |
Phase 1 |
Apr/24/2020 |
Jul/30/2020 |
- Alternative id - 2206
- Interventions - Drug: Methylene Blue and Photodynamic Therapy
- Study type - Interventional
- Study results - No Results Available
- Locations - I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 60
- Age - 18 Years to 90 Years (Adult, Older Adult)
- Outcome measures - The percentage of participants with negative quantitative Polymerase Chain Reaction test on SARS-CoV-2 on day 2 after methylene blue administration and photodynamic therapy|Comparison of oxygen saturation dynamics measured by pulse oximeter before and after treatment|The percentage of participants with positive dynamics in severity of pneumonia (e.g., from CT-4 to CT-2)|The percentage of participants having positive dynamics in patient status scale (EQ-5D-3L, SHOCS-COVID score) after treatment|The percentage of participants alive at day 28|The percentage of participants alive at day 84
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NCT05004805
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COVID-19 Methylene Blue Antiviral Treatment |
Completed |
Phase 2 |
Aug/06/2021 |
Dec/12/2021 |
- Alternative id - COMBAT
- Interventions - Drug: Methylene Blue|Drug: Saline nasal spray
- Study type - Interventional
- Study results - No Results Available
- Locations - Irkutsk Regional Hospital, Irkutsk, Irkutskaya Oblast, Russian Federation
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 24
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Recovery|Clinical responce|Overall therapeutic response|Resolution rate|Clinical responce FUV|Overall therapeutic response FUV
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NCT04370288
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Clinical Application of Methylene Blue for Treatment of Covid-19 Patients |
Recruiting |
Phase 1 |
Apr/19/2020 |
Sep/21/2020 |
- Alternative id - IR.MUMS.REC.1399.122
- Interventions - Drug: MCN (Methylene blue, vitamin C, N-acetyl cysteine)
- Study type - Interventional
- Study results - No Results Available
- Locations - Imam Reza Hospital, Mashhad, Razavi Khorasan, Iran, Islamic Republic of
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 20
- Age - 18 Years to 90 Years (Adult, Older Adult)
- Outcome measures - Proportion of patients remaining free of need for mechanical ventilation in both groups|Mortality rate in both groups|Improvement in Pa02/Fi02 ratio in both groups|Duration of hospital stay in both group.|Duration of Intensive Care Unit stay in both groups|Days free of dialysis in both groups|C-reactive proteins|WBC Count
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NCT04635605
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Methylene Blue Treatment of COVID-19 |
Recruiting |
Phase 2 |
Nov/05/2020 |
Dec/31/2022 |
- Alternative id - MB treatment of COVID19
- Interventions - Drug: Methylene Blue|Drug: Control Test
- Study type - Interventional
- Study results - No Results Available
- Locations - Fondazione Epatocentro Ticino, Lugano, Ticino, Switzerland
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 64
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - to compare the viral load kinetics in the enrolled patients with a SARS-CoV-2 positive nasopharyngeal swab demonstrating a reduction of the area under the curve day 0- day 21 of at least 25%|To calculate the percentage of patients clearing SARS-CoV-2 by 3, 6, 9, 12, 15 and 21 days after diagnosis|To calculate the percentage of patients having a reduction of viral load of > 2 log by day 3|To calculate the percentage of patients having a poor outcome as measured by the need of hospitalization for COVID-19|To calculate the percentage of patients alive|Safety and tolerability of the administered drug are registered as "adverse events", which are all symptoms related or supposed to be related to the drug that appeared after the drug intake and were NOT present at baseline or before|To measure the compliance by calculating the number of capsules taken by the patient and the overall number of patients who complete the treatment
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