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NCT04425772
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A Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19） |
Not yet recruiting |
Not Applicable |
Jun/12/2020 |
Aug/12/2020 |
- Alternative id - FNC-Hope4
- Interventions - Drug: FNC+Standard of Care|Drug: FNC dummy tablet+Standard of Care
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 342
- Age - 18 Years to 99 Years (Adult, Older Adult)
- Outcome measures - Change (reduction) in viral load from baseline|proportion of subjects change from mild or moderate type to severe type|proportion of subjects change from severe type to critical type|novel coronavirus nucleic acid conversion rate|Novel coronavirus nucleic acid negative conversion time|The time and proportion of improvement in pulmonary imaging|Time and proportion of temperature return to normal|time and rate of improvement of respiratory symptoms and signs (lung rhones, cough, sputum, sore throat, etc.)|time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms|Changes of blood oxygen detection index|Frequency of requirement for supplemental oxygen or non-invasive ventilation|Frequency of adverse events
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NCT04668235
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Study on Safety and Clinical Efficacy of AZVUDINE in COVID-19 Patients (SARS-CoV-2 Infected) |
Recruiting |
Phase 3 |
Apr/23/2021 |
Apr/01/2022 |
- Alternative id - FNC IGZ-1
- Interventions - Drug: AZVUDINE|Drug: AZVUDINE placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Santa Casa de Misericordia de Campos, Campos Dos Goytacazes, RJ, Brazil
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 342
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Evaluation of clinical improvement of AZVUDINE (FNC) in COVID-19 treatment|Clinical cure outcome rate|Recovery of body temperature|Clinical improvement of diarrhea, myalgia fatigue and other symptoms|Assessment of inflammatory biochemical markers (Reactive C Protein, erythrocyte sedimentation rate, and Procalcitonin)|Assessment of immunological function biochemical markers (IL-6, IgG, IgM, IgA, and complement factor C3 and C4)|Assessment of renal function biochemical markers (serum creatinine and calculated glomerular filtration rate)|Assessment of liver function biochemical markers (AST/TGO, ALT/TGP, ALP, GGT, BIL total, and direct BIL)|Evaluation of time to negative conversion of SARS-CoV-2 viral load by RT-PCR|Evaluation of the number of cycles for the detection of SARS-CoV-2 viral load by RT-PCR and application of the standard curve for calculating viral load|Analysis of the relationship between the calculated viral load and the clinical evolution of the participants in the experimental group (FNC) and the PLACEBO group|Time for improvement of pulmonary condition by imaging exams during treatment|Evaluation of pulmonary condition by imaging exams during treatment|Time for clinical improvement of respiratory signs and symptoms|Assessment of clinical improvement of respiratory signs and symptoms|Time for normalization of O2 saturation|Respiratory rate evaluation|Frequency of supplemental oxygenation or non-invasive ventilation|Frequency of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO|Proportion of moderate cases that progressed to severe cases|Assessment of hospitalization time|Evaluation of drug interaction events frequency|Evaluation of drug interaction events intensity|Assessment of adverse events frequency|Assessment of adverse events intensity|Assessment of unexpected adverse events frequency|Assessment of unexpected adverse events intensity|Assessment of serious adverse events frequency|Assessment of serious adverse events intensity|Overall mortality rate|Evaluation of the tolerability of azvudine in the 5 mg regimen orally QD up to 14 days|Assessment of adherence of azvudine in the 5 mg regimen orally QD up to 14 days|Time of use of azvudine in the 5 mg regimen orally QD up to 14 days
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NCT05033145
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Study on Safety and Clinical Efficacy of AZVUDINE in Initial Stage COVID-19 Patients (SARS-CoV-2 Infected) |
Not yet recruiting |
Phase 3 |
Oct/01/2021 |
Jul/01/2022 |
- Alternative id - FNC IGZ-2
- Interventions - Drug: AZVUDINE|Drug: AZVUDINE placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Clinical Research Unit / High Complexity Center (CRU/HCC) / Galzu Institute, Campos Dos Goytacazes, Rio De Janeiro, Brazil|Hospital Moacyr Gomes de Azevedo, Cambuci, RJ, Brazil|Hospital Santa Casa de Misericórdia de Campos, Campos Dos Goytacazes, RJ, Brazil|Unidade de Pesquisa Clínica / Centro de Alta Complexidade, Campos dos Goytacazes, RJ, Brazil|Unidade Pré Hospitalar São José, Campos Dos Goytacazes, RJ, Brazil|Hospital de Itaocara, Itaocara, RJ, Brazil|Hospital Armando Vidal, São Fidelis, RJ, Brazil
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 312
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Hospitalized patients proportion during the study|Proportion of participants with clinical evolution of cure during the study|Improvement of participant clinical status|Severity and duration of clinical symptoms|Assessment of renal function biochemical markers (serum creatinine and calculated glomerular filtration rate)|Assessment of liver function biochemical markers (AST/TGO, ALT/TGP, ALP, GGT, BIL total, and direct BIL)|Evaluation of time to negative conversion of SARS-CoV-2 viral load by RT-PCR|Evaluation of the number of cycles for the detection of SARS-CoV-2 viral load by RT-PCR and application of the standard curve for calculating viral load.|Analysis of the relationship between the calculated viral load and the clinical evolution of the participants in experimental (FNC) and PLACEBO groups.|Evaluation of drug interaction events.|Overall mortality assessment.|Assessment of adverse events frequency.|Assessment of adverse events intensity.|Assessment of unexpected adverse events frequency.|Assessment of unexpected adverse events intensity.|Assessment of serious adverse events frequency.|Assessment of serious adverse events intensity.|Evaluation of the tolerability of azvudine in the 5 mg regimen orally QD up to 14 days.|Assessment of adherence of azvudine in the 5 mg regimen orally QD up to 14 days.|Time of use of azvudine in the 5 mg regimen orally QD up to 14 days.
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