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NCT04534725
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COVID-19 Prevention and Treatment in Cancer; a Sequential Multiple Assignment Randomised Trial; |
Recruiting |
Phase 3 |
Dec/17/2020 |
Dec/01/2021 |
- Alternative id - Peter Mac ID 20/135
- Interventions - Drug: Interferon alfa|Drug: Selinexor|Drug: Lenzilumab
- Study type - Interventional
- Study results - No Results Available
- Locations - Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
- Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 2282
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Incidence of COVID-19 in cancer patients using interferon-alpha as prophylaxis without known positive contact with COVID-19 (COVID-19 confirmed by qPCR from respiratory swab)|incidence of any upper or lower community acquired respiratory viral infection assessed using local standard of care testing|incidence of COVID-19 when Interferon alpha is given as post-exposure prophylaxis with a known positive contact or exposure with COVID-19. COVID-19 confirmed by qPCR from respiratory swab .|incidence of death and/or need for invasive or non-invasive ventilation. assessed using medical records|time to clinical improvement or discharge from hospital assessed using medical records|ARM 1: Duration of acute respiratory/ILI symptoms in case of confirmed respiratory infection during the study period. Assessed using patient symptom Diary PRO tool|ARM 1: Time to diagnosis of COVID-19 in case of confirmed COVID-19 diagnosed during the study period (days). Assessed using patient medical records|ARM 1: Time to diagnosis of other respiratory viral infection in case of confirmed other respiratory viral infection diagnosed during the study period (days). assessed using patient medical records|ARM 1: Illness severity in case of confirmed COVID-19 diagnosed during the study period using WHO clinical progression scale|ARM 1: Incidence of unplanned all-cause hospital admission during the study period. assessed using medical records|ARM 1: Incidence of unplanned infection-related hospital admission during the study period. assessed using medical records|ARM 1: Incidence of sero-conversion of SARS-CoV-2 at the end of the study period. assessed using qPCR|ARM 1: Incidence of death from any cause during the study period. assessed using patient medical records|ARM 1: Incidence of testing for COVID-19 during the study period. assessed using medical records|ARM 2 Duration of acute respiratory symptoms in case of confirmed COVID-19 diagnosed during the study period. assessed with PRO and medical records.|ARM 2: Time to diagnosis of COVID-19 in case of confirmed COVID-19 diagnosed during the study period (days). assessed using medical records|ARM 2: Illness severity in case of confirmed COVID-19 diagnosed during the study period. assessed using WHO clinical progression scale.|ARM 2: Incidence of unplanned all-cause hospital admission during the study period. assessed using medical records.|ARM 2: Incidence of unplanned infection-related hospital admission during the study period. assessed using medical records|ARM 2: Incidence of seroconversion of SARS-CoV-2 at the end of the study period. assessed using qPCR.|ARM 2: Incidence of testing for COVID-19 during the study period assessed using medical records|ARM 3: Time to clinical improvement assessed using medical records.|ARM 3: Illness severity of COVID-19, defined as the maximal score on the World Health Organization (WHO)'s clinical progression ordinal scale|ARM 3: change to clinical condition assessed with Karnofsky Performance score|ARM 3: Time to progression to severe COVID-19, defined by WHO ordinal scale|ARM 3: Time to all-cause mortality|ARM 3:Duration of hospitalisation assessed using medical records|ARM 3: Duration of COVID-19 symptoms assessed using patient reported symptom diary.|ARM 3: Duration of oxygen supplementation (days). assessed using medical records.|ARM 3: change in nasopharyngeal SARS-CoV-2 viral load shedding (assessed via qPCR)|ARM 3: Safety and tolerability of selinexor using relevant medical records|ARM 3: incidence of changes in blood results relevant to clinical improvement assessed using medical records|ARM 4: Incidence of all cause death by day 28 and 60|ARM 4: Time to all-cause mortality|ARM 4: Illness severity of COVID-19, defined as the maximal score on the World Health Organization (WHO)'s clinical progression ordinal scale|ARM 4: Incidence of ARDS assessed using medical records|ARM 4: incidence of HLH. assessed using medical records|ARM 4: Duration of hospitalisation. assessed using hospital medical records.|ARM 4: Proportion discharged from hospital. assessed using medical records|ARM 4: Incidence of mechanical ventilation up to day 28. assessed using medical records|ARM 4: Ventilator-free days and proportion who did not receive invasive mechanical ventilation. assessed using medical records|ARM 4: Organ failure free days and proportion who did not develop organ failure. assessed using medical records.|ARM 4: Incidence and duration of ICU admission. assessed using medical records|ARM 4: incidence and duration of supplemental oxygen use. assessed using medical records|ARM 4: Time to clinical improvement defined as National Early Warning Score 2 (NEWS2) of <2 maintained for 24 hours.|ARM 4: incidence of non-invasive ventilation. assessed using medical records|ARM 4: number of participants alive and off oxygen at day 60. assessed using medical records.|ARM 4: proportion of participants who had improved oxygenation for >48 hours. assessed using medical records|ARM 4: Incidence of adverse events based on the national cancer institute CTCAE v5. Assessed using medical records|ARM 4: incidence of SAEs based on NCI CTCAE v5 assessed using medical records|ARM 4: change in nasopharyngeal SARS-CoV-2 viral load shedding. assessed using qPCR.
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NCT04293887
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Efficacy and Safety of IFN-α2β in the Treatment of Novel Coronavirus Patients |
Unknown status |
Early Phase 1 |
Mar/01/2020 |
Jun/30/2020 |
- Alternative id - Zhaojp
- Interventions - Drug: Recombinant human interferon α1β
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 328
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - The incidence of side effects|Time from patient enrollment to clinical remission|Proportion of patients with normal body|Proportion of patients without dyspnea|Proportion of patients without cough|Proportion|The negative conversion rate of new coronavirus nucleic acid|Frequency of serious adverse drug events.
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NCT04379518
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Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients |
Recruiting |
Phase 1|Phase 2 |
Nov/17/2020 |
Nov/17/2023 |
- Alternative id - I 659920|NCI-2020-02317|P30CA016056
- Interventions - Other: Best Practice|Biological: Recombinant Interferon Alfa-2b|Drug: Rintatolimod
- Study type - Interventional
- Study results - No Results Available
- Locations - Roswell Park Cancer Institute, Buffalo, New York, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 64
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Incidence of adverse events (AEs)|Kinetics of viral load|Clinical efficacy|Kinetics of changes of the immune subsets and circulating inflammatory mediators in peripheral blood
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NCT04320238
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Experimental Trial of rhIFNα Nasal Drops to Prevent 2019-nCOV in Medical Staff |
Unknown status |
Phase 3 |
Jan/21/2020 |
Jun/01/2020 |
- Alternative id - Interferon_prophylaxis
- Interventions - Drug: recombinant human interferon Alpha-1b|Drug: thymosin alpha 1
- Study type - Interventional
- Study results - No Results Available
- Locations - Taihe Hospital, Shiyan, Hubei, China
- Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 2944
- Age - 18 Years to 65 Years (Adult, Older Adult)
- Outcome measures - new-onset COVID-19|Number of Participants with coronavirus related symptoms|Number of Participants with adverse effect
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NCT04664010
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Efficacy and Safety of High-dose Vitamin C Combined With Chinese Medicine Against Coronavirus Pneumonia (COVID-19) |
Active, not recruiting |
Not Applicable |
Feb/06/2020 |
Jan/31/2021 |
- Alternative id - XianInternationalMCH_HXJ
- Interventions - Drug: Alpha-interferon alpha, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste, fumigation/inhalation of vitamin C|Drug: Alpha-interferon, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste and 5% glucose|Drug: Alpha-interferon, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste and high-dose vitamin C treatment
- Study type - Interventional
- Study results - No Results Available
- Locations - Xi'an International Medical Center Hospital, Xi'an, Shaanxi, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
- Enrollment - 60
- Age - 18 Years to 70 Years (Adult, Older Adult)
- Outcome measures - Recovery time|Time of disappearance of fever symptoms|The rate of conversion from COVID-19 positive to COVID-19 negative|Time of disappearance of cough|Respiratory rate|Blood oxygen saturation|PaO2|PaCO2|The time of obvious improvement as shown on chest CT scans relative to admission|The rate of obvious improvement as shown on chest CT scans relative to admission|Levels of C-reactive protein|Erythrocyte sedimentation rate|Levels of Procalcitonin|Levels of interleukin-6|Levels of interleukin-10|Levels of tumor necrosis factor-alpha
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