Covid 19 Research using Clinical Trials (Home Page)
FavipiravirWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (42)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1095 | Favipiravir Placebo Wiki | 0.32 |
| drug1094 | Favipiravir Combined With Tocilizumab Wiki | 0.23 |
| drug1365 | IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki | 0.23 |
| drug1569 | Liberase Enzyme (Roche) Wiki | 0.23 |
| drug1984 | Only Standard Treatment Wiki | 0.23 |
| drug1430 | Inspiratory training device Wiki | 0.23 |
| drug1674 | Maintenance or reduction of immunosuppression Wiki | 0.23 |
| drug631 | Centricyte 1000 Wiki | 0.23 |
| drug2000 | Other drugs Wiki | 0.23 |
| drug3093 | VivaDiag™ COVID-19 lgM/IgG Rapid Test Wiki | 0.23 |
| drug2710 | Standard of care management Wiki | 0.23 |
| drug1046 | Expiratory training device Wiki | 0.23 |
| drug1746 | Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki | 0.23 |
| drug1424 | Inhaled nitric oxide gas Wiki | 0.23 |
| drug2743 | Sterile Normal Saline for Intravenous Use Wiki | 0.23 |
| drug3469 | standard concomitant therapy Wiki | 0.23 |
| drug1600 | Lopinavir/ Ritonavir Placebo Wiki | 0.23 |
| drug1598 | Lopinavir/ Ritonavir Wiki | 0.23 |
| drug1908 | Non-contact MCE system Wiki | 0.23 |
| drug2708 | Standard of care (SOC) Wiki | 0.16 |
| drug2468 | Routine care for COVID-19 patients Wiki | 0.16 |
| drug2713 | Standard of care treatment Wiki | 0.16 |
| drug1862 | Niclosamide Wiki | 0.16 |
| drug2259 | Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health Wiki | 0.13 |
| drug1875 | Nitric Oxide Wiki | 0.11 |
| drug1841 | Nasopharyngeal swab Wiki | 0.11 |
| drug1586 | Lopinavir / Ritonavir Wiki | 0.10 |
| drug603 | Camostat Mesilate Wiki | 0.10 |
| drug812 | DAS181 Wiki | 0.09 |
| drug3206 | blood sample Wiki | 0.09 |
| drug1284 | Hydroxychloroquine Wiki | 0.09 |
| drug2161 | Placebo oral tablet Wiki | 0.08 |
| drug654 | Chloroquine Wiki | 0.08 |
| drug1869 | Nitazoxanide Wiki | 0.07 |
| drug2176 | Placebos Wiki | 0.06 |
| drug1887 | No intervention Wiki | 0.05 |
| drug2413 | Remdesivir Wiki | 0.05 |
| drug1489 | Ivermectin Wiki | 0.05 |
| drug2122 | Placebo Wiki | 0.05 |
| drug2698 | Standard of Care Wiki | 0.04 |
| drug2928 | Tocilizumab Wiki | 0.04 |
| drug313 | Azithromycin Wiki | 0.04 |
Correlated MeSH Terms (23)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D003141 | Communicable Diseases NIH | 0.25 |
| D011649 | Pulmonary Alveolar Proteinosis NIH | 0.23 |
| D054990 | Idiopathic Pulmonary Fibrosis NIH | 0.23 |
| D007239 | Infection NIH | 0.18 |
| D011565 | Psoriasis NIH | 0.16 |
| D004066 | Digestive System Diseases NIH | 0.13 |
| D005767 | Gastrointestinal Diseases NIH | 0.13 |
| D003428 | Cross Infection NIH | 0.13 |
| D016739 | Behavior, Addictive NIH | 0.11 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.10 |
| D018352 | Coronavirus Infections NIH | 0.10 |
| D011658 | Pulmonary Fibrosis NIH | 0.09 |
| D004417 | Dyspnea NIH | 0.08 |
| D014777 | Virus Diseases NIH | 0.08 |
| D019966 | Substance-Related Disorders NIH | 0.08 |
| D017563 | Lung Diseases, Interstitial NIH | 0.07 |
| D007251 | Influenza, Human NIH | 0.06 |
| D012120 | Respiration Disorders NIH | 0.06 |
| D011024 | Pneumonia, Viral NIH | 0.06 |
| D008171 | Lung Diseases, NIH | 0.05 |
| D012140 | Respiratory Tract Diseases NIH | 0.05 |
| D004630 | Emergencies NIH | 0.04 |
| D011014 | Pneumonia NIH | 0.01 |
Correlated HPO Terms (9)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0006517 | Intraalveolar phospholipid accumulation HPO | 0.23 |
| HP:0003765 | Psoriasiform dermatitis HPO | 0.16 |
| HP:0030858 | Addictive behavior HPO | 0.11 |
| HP:0011024 | Abnormality of the gastrointestinal tract HPO | 0.09 |
| HP:0002206 | Pulmonary fibrosis HPO | 0.09 |
| HP:0002098 | Respiratory distress HPO | 0.08 |
| HP:0006515 | Interstitial pneumonitis HPO | 0.07 |
| HP:0002088 | Abnormal lung morphology HPO | 0.05 |
| HP:0002090 | Pneumonia HPO | 0.01 |
There are 19 clinical trials
Clinical Trials
1 Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019-A Multicenter, Randomized and Controlled Clinical Trial Study
The purpose of this study is to evaluate the efficacy and safety of favipiravir combined with tocilizumab in the treatment of corona virus disease 2019.
NCT04310228 COVID-19 Drug: Favipiravir Combined With Tocilizumab Drug: Favipiravir Drug: Tocilizumab MeSH:Coronavirus Infections Virus Diseases
Primary Outcomes
Description: Definition of clinical cure: The viral load of the respiratory specimen was negative for two consecutive times (the interval between the two tests was greater than or equal to one day), the lung image improved, and the body temperature returned to normal for more than 3 days, and the clinical manifestation improved.
Measure: Clinical cure rate Time: 3 monthsSecondary Outcomes
Measure: Viral nucleic acid test negative conversion rate and days from positive to negative Time: 14 days after taking medicineMeasure: Duration of fever Time: 14 days after taking medicine
Measure: Lung imaging improvement time Time: 14 days after taking medicine
Measure: Mortality rate because of Corona Virus Disease 2019 Time: 3 months
Measure: Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs Time: 3 months
Measure: Mean in-hospital time Time: 3 months
2 The Mechanism, Clinical Outcome and Therapeutic Intervention of Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive
To investigate the mechanism, clinical outcome and therapeutic efficacy with favipiravir of Corona Virus Disease 2019 patients whose nucleic acids changed from negative to positive.
NCT04333589 COVID-19 Drug: Favipiravir MeSH:Coronavirus Infections Virus Diseases
Primary Outcomes
Description: Proportion of subjects who tested negative for nucleic acid from sputum or nasopharyngeal swabs for two consecutive times(sampling time at least 24 hours).
Measure: Viral nucleic acid test negative conversion rate Time: 5 monthsSecondary Outcomes
Description: Definition of clinical cure: The viral load of the respiratory specimen was negative for two consecutive times (the interval between the two tests was greater than or equal to one day), the lung image improved, and the body temperature returned to normal for more than 3 days, and the clinical manifestation improved.
Measure: Clinical cure rate Time: 5 months3 A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Study Evaluating the Efficacy and Safety of Favipiravir in the Treatment of Patients With COVID-19-Moderate Type
This study evaluates treatment with Favipiravir combined with supportive care for adult patients with COVID-19-moderate type.
NCT04336904 COVID-19 Drug: Favipiravir Other: Placebo
Primary Outcomes
Description: The duration from start of treatment (Favipiravir or placebo) to normalization of pyrexia, respiratory rate and SPO2 and relief of cough (where there are relevant abnormal symptoms at enrolment) that is maintained for at least 72 hours.
Measure: Time from randomization to clinical recovery Time: 90 daysSecondary Outcomes
Description: 1. Time from randomization to negativity in RT-PCR nucleic acid test for 2019-nCov within 28 days of randomization;
Measure: Time from randomization to negativity in RT-PCR nucleic acid test Time: 28 daysDescription: Incidence of deterioration/aggravation of pneumonia (defined as SPO2≤93% or PaO2/FiO2 ≤300 mmHg or distressed RR≥30/min without oxygen inhalation and requiring oxygen therapy or more advanced breath support) within 28 days of randomization;
Measure: Incidence of deterioration/aggravation of pneumonia Time: 28 daysDescription: Time from randomization to resolution of pyrexia (defined the same as for the primary efficacy variable; applicable to subjects with pyrexia at enrolment) within 28 days of randomization;
Measure: Time from randomization to resolution of pyrexia Time: 28 daysDescription: Time from randomization to relief of cough (defined the same as for the primary efficacy variable; applicable to subjects with cough at enrolment) within 28 days of randomization; It is recommended that the severity of cough be graded as per NCI-CTCAE v5.0: Mild: Requires non-prescription treatment; Moderate: Requires medication treatment; limits instrumental activities of daily living; Severe: Limits self-care activities of daily living
Measure: Time from randomization to relief of cough Time: 28 daysDescription: Time from randomization to relief of dyspnoea (defined as subject-perceived improvement or resolution of dyspnoea; applicable to subjects with dyspnoea at enrolment) within 28 days of randomization;
Measure: Time from randomization to relief of dyspnoea Time: 28 daysDescription: 6. Rate of auxiliary oxygen therapy or non-invasive ventilation within 28 days of randomization
Measure: Rate of auxiliary oxygen therapy Time: 28 daysDescription: ICU admission rate within 28 days of randomization
Measure: ICU admission rate Time: 28 daysDescription: All-cause mortality within 28 days of randomization
Measure: Mortality Time: 28 days4 The Results of COVID 19 Treatment: A Real-life Experience on Patients With COVID 19
COVID 19 treatment using Chloroquine with or without Azithromycin, Faviprevir, Nitazoxanide, Ivermectin.
NCT04345419 COVID Drug: Chloroquine Drug: Favipiravir Drug: Nitazoxanide Drug: Ivermectin Drug: Niclosamide Drug: Other drugs
Primary Outcomes
Description: the estimated number of patients with decreased viral load
Measure: Number of patients with decreased viral load Time: 6 months5 A Phase 2 Randomized, Double Blinded, Placebo Controlled Study of Oral Favipiravir Compared to Standard Supportive Care in Subjects With Mild or Asymptomatic COVID-19
The objective of this study is to evaluate the efficacy of oral favipiravir plus standard of care treatment (SOC) compared with placebo plus SOC in reducing the duration of shedding of SARS-CoV2 virus in patients with mild or asymptomatic COVID-19.
NCT04346628 Sars-CoV2 COVID-19 Drug: Favipiravir Drug: Placebo Other: Standard of care treatment
Primary Outcomes
Description: Time in days from randomization to the first two negative results of nasal and/or oropharyngeal swab.
Measure: Time until cessation of oral shedding of SARS-CoV-2 virus Time: Up to 28 daysSecondary Outcomes
Description: Viral load will be assessed as the TCID50 (Median Tissue Culture Infectious Dose) over time.
Measure: Sars-CoV-2 viral load Time: Up to 28 daysDescription: Clinical worsening will be determined by clinician assessment.
Measure: Count of participants with clinical worsening of COVID-19 disease Time: Up to 28 daysMeasure: Count of participants with development of SARS-CoV-2 antibodies Time: Up to 28 days
Measure: Time until cessation of symptoms Time: Up to 28 days
Description: This outcome will be assessed in patient who are asymptomatic of COVID-19 infection at the time of enrollment
Measure: Count of participant with absence of development of any symptoms Time: Up to 28 daysDescription: Cmax is a pharmacokinetic parameter that measures the maximum concentration of drug in plasma.
Measure: Cmax of favipiravir Time: Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration)Description: Cmin is a pharmacokinetic parameter that measures the minimum concentration of drug in plasma.
Measure: Cmin of favipiravir Time: Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration)6 Clinical Study Evaluating the Efficacy of Faviprevir in COVID-19 Treatment
Faviprevir in COVID-19 treatment
NCT04351295 COVID Drug: Favipiravir Drug: Placebos
Primary Outcomes
Description: The total number of patients with viral cure
Measure: Number of patients with viral cure Time: 6 months7 Efficacy and Safety of Favipiravir Compared to the Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized, Controlled, Double-Blind, Clinical Trial
The present study is a randomized, double-blind, controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
NCT04359615 COVID-19 Drug: Favipiravir Drug: Hydroxychloroquine
Primary Outcomes
Description: Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first.
Measure: Time to clinical improvement Time: From date of randomization until 14 days later.Secondary Outcomes
Description: If the patient dies, we have reached an outcome.
Measure: Mortality Time: From date of randomization until 14 days later.Description: Pulse-oxymetry
Measure: oxygen saturation by pulse oximetry (SpO2) Improvement Time: Days 1, 2, 3, 4, 5, 6, 7 and 14.Description: Incidence of new mechanical ventilation use
Measure: Incidence of new mechanical ventilation use Time: From date of randomization until 14 days later.Description: Duration of hospitalization (days)
Measure: Duration of hospitalization Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 14 days.Description: With incidence of any serious adverse effects, the outcome has happened.
Measure: Cumulative incidence of serious adverse events Time: Days 1, 2, 3, 4, 5, 6, 7 and 14.8 A Randomised Controlled Trial of Early Intervention in Patients HospItalised With COVID-19: Favipiravir and StaNdard Care vErsEs Standard CaRe
Currently we do not know how best to treat patients infected with COVID-19. This study is looking at whether randomising participants to either favipiravir or to usual care, can help patients with suspected or proven COVID-19 infection.
NCT04373733 Coronavirus Infection Drug: Favipiravir Other: Standard of care management MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome
Primary Outcomes
Description: Time from randomisation to clinical improvement by two points on a seven-category ordinal scale: Not hospitalised with resumption of normal activities Not hospitalised, but unable to resume normal Hospitalised, not requiring supplemental oxygen Hospitalised, requiring supplemental oxygen Hospitalised, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation or both Hospitalised, requiring ECMO (Extra-corporal membrane oxygenation), invasive mechanical ventilation or both Death
Measure: Time to improvement by two points on a seven-category ordinal scale Time: Up to 28 days from randomisationSecondary Outcomes
Description: Clinical status of patients at given on the seven-category ordinal scale (see primary endpoint for scale)
Measure: Clinical status on a seven-category ordinal scale (Day 7) Time: Day 7 from randomisationDescription: Clinical status of patients at given on the seven-category ordinal scale (see primary endpoint for scale)
Measure: Clinical status on a seven-category ordinal scale (Day 14) Time: Day 14 from randomisationDescription: Survival of patients to end of study
Measure: Overall survival Time: 28 days from randomisationDescription: Time from randomisation to improvement by two points on the NEWS score of patient condition, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2
Measure: Time to improvement by two points on the NEWS score Time: Up to 28 days from randomisationDescription: Time from randomisation to improvement by two points on the NEWS element score for temperature, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2
Measure: Time to improvement by two points on the NEWS element score for temperature Time: Up to 28 days from randomisationDescription: Time from randomisation to improvement by two points on the NEWS element score for heartrate, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2
Measure: Time to improvement by two points on the NEWS element score for heartrate Time: Up to 28 days from randomisationDescription: Time from randomisation to improvement by two points on the NEWS element score for respiratory rate, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2
Measure: Time to improvement by two points on the NEWS element score for respiratory rate Time: Up to 28 days from randomisationDescription: Time from randomisation to improvement by two points on the NEWS element score for oxygen saturation, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2
Measure: Time to improvement by two points on the NEWS element score for oxygen saturation. Time: Up to 28 days from randomisationDescription: Frequency of admission of patients to intensive care
Measure: Admission to intensive care Time: Up to 28 days from randomisationDescription: Frequency of requirement to administer mechanical ventilation to patients
Measure: Requirement for mechanical ventilation Time: Up to 28 days from randomisationDescription: Frequency of requirement to administer non-invasive ventilation, continuous positive airways pressure or high-flow oxygen to patients
Measure: Requirement for non-invasive ventilation, continuous positive airways pressure or high-flow oxygen Time: Up to 28 days from randomisationDescription: Frequency of culture-confirmed bacterial or fungal infection in patients
Measure: Incidence of bacterial or fungal infection Time: Up to 28 days from randomisationDescription: Frequency and severity of adverse events in patients not directly attributed by clinicians to COVID-19 infection.
Measure: Incidence of adverse events not directly caused by COVID-19 infection. Time: Up to 28 days from randomisation.Other Outcomes
Description: Frequency of readmission to inpatient care of patients discharged from hospital.
Measure: Readmission to inpatient care Time: Up to 28 days from randomisation9 The Regimen of Favipiravir Plus Hydroxychloroquine Can Accelerate Recovery of the COVID-19 Patients With Moderate Severity in Comparison to Lopinavir/Ritonavir Plus Hydroxychloroquine Regimen: an Open-label, Non-randomized Clinical Trial Study
This is an open-label, non-randomized clinical trial study. The number of 40 COVID-19 patients with moderate severity will be admitted in progressive care units (PCUs) and intensive care units (ICUs) enrolled in the study. The sampling will be purposive and based on the same independent variables, including age, gender, past medical histories, and the situation of the patient at the admission day, and ventilator support. The patients will be allocated into two groups with different regimens. Group "A" (regimen A)will be defined as Favipiravir 1600 mg a first dose and 600 mg in 3 divided doses daily plus 400 mg in 2 divided doses of Hydroxychloroquine every day. The group "B" (regimen B) will be contained 400 mg of Lopinavir/Ritonavirin 2 divided doses plus the first dose (400 mg) of Hydroxychloroquine. Hydroxychloroquine will not be used for adverse drug reactions. The regimen remained at least 7 up to 10 days. Data will be analyzed using statistical package for social sciences (SPSS) version 18 (SPSS Inc. Chicago, IL, USA) for windows. The variables will be compared using independent and paired T-test for normally distributed variables and Wilcoxon, Chi-square for non-normal distributed variables. The Kaplan Meier test will be used for survival analysis and the one-sample Kolmogorov-Smirnov test for the evaluation of distributions.
NCT04376814 COVID-19 Favipiravir Kaletra Hydroxychloroquine Lopinavir/Ritonavir Drug: Favipiravir Drug: Hydroxychloroquine Drug: Lopinavir / Ritonavir
Primary Outcomes
Description: In-hospital mortality
Measure: Mortality Time: Up to 28 daysDescription: long of hospitalization
Measure: long of hospitalization Time: Up to 28 daysDescription: Laboratory Treatment Response; return of blood cell count to normal
Measure: Laboratory Treatment Response (Blood cell count) Time: Up to 28 daysDescription: Laboratory Treatment Response; return of CRP values to normal
Measure: Laboratory Treatment Response (CRP ) Time: Up to 28 daysDescription: shortness of breath based on symptoms of Dyspnea and questioning the patient
Measure: Dyspnea Time: Up to 28 daysDescription: Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes.
Measure: Oxygen saturation without supplemental oxygen. Time: Up to 28 daysDescription: Oxygen therapy maximum flow during the day (lit/min)
Measure: Oxygen therapy Time: Up to 28 days10 Treatment of Covid-19 With Favipiravir Versus Hydroxychloroquine: a Randomized Comparator Trial
Hydroxychloroquine is widely used to treat autoimmune diseases. Clinical investigation has found that a high concentration of cytokines were detected in the plasma of critically ill patients infected with SARS-CoV-2, therefore, hydroxychloroquine as anti-inflammatory agents may reduce this response in accord with their use in autoimmune disease where the cytokine response can be reduced. Favipiravir is an antiviral drug developed in Japan that the data sheet notes that it is a pyrazinecarboxamide derivative with activity against influenza viruses, west nile virus, yellow fever virus, foot and mouth disease virus as well as against flaviviruses, arenaviruses, bunyaviruses and alphaviruses. In February the drug was used for COVID-19 disease in China and was declared effective in treatment, and a report published (in press) comparing Favipiravir with Lopinavir /ritonavir suggested that Favipiravir was superior for prevention of disease progression and viral clearance. The objective of this pilot study is to compare three arms: hydroxychloroquine; favipiravir; standard care (no specific SARS-CoV-2 treatment) only, in symptomatic patients infected by SARS-CoV-2 in an open label randomized clinical trial. The difference between groups will allow an effect size to be determined for a definitive clinical trial.
NCT04387760 SARS-CoV 2 COVID-19 Drug: Hydroxychloroquine Drug: Favipiravir Other: Routine care for COVID-19 patients
Primary Outcomes
Description: Single negative SARS-CoV2 PCR NP Swab
Measure: Primary outcome measure will be time to viral clearance Time: Until discharge or for a maximum of 14 days or readmissionSecondary Outcomes
Description: Implementation of escalation of Respiratory Support
Measure: Requirement of Escalation of Respiratory Support Time: Until discharge or for a maximum of 14 days or readmissionDescription: Monitor and document all adverse effects during therapy
Measure: Adverse effects(cardiac, renal, hepatic, hypoglycaemia (defined as RBS <3.9 mmol/L)) Time: Until discharge or for a maximum of 14 days or readmissionDescription: Deterioration of clinical condition requiring ICU admission
Measure: Requirement of ICU Admission Time: Until discharge or for a maximum of 14 days or readmissionDescription: Mortality rate due to COVID-19
Measure: Mortality rate Time: Mortality will be collected up to 30 dayDescription: Determination of the change in lactate levels before and after treatment as a measure of disease activity
Measure: Serum lactate measurement Time: Until discharge or for a maximum of 14 days or readmissionDescription: Determination of the change in ferritin levels before and after treatments as a measure of disease activity
Measure: Serum Ferritin measurement Time: Until discharge or for a maximum of 14 days or readmissionDescription: Determination of the change in D Dimer levels before and after treatments as a measure of disease activity
Measure: Serum D Dimer measurement Time: Until discharge or for a maximum of 14 days or readmissionDescription: Determination of the change in Ratio of Lymphocyte to Neutrophil, before and after treatments as a measure of disease activity
Measure: Ratio of Lymphocyte to Neutrophil, measurement Time: Until discharge or for a maximum of 14 days or readmissionDescription: Patients will be followed during their hospital stay until discharge
Measure: Discharge and Length of Hospital Stay Time: Until discharge or for a maximum of 14 days or readmissionDescription: Capturing readmission data
Measure: Readmission Rate Time: Until 30 days from the start of the trialDescription: SOFA score can identify the critical point at which patients exhibit the highest degree of organ dysfunction
Measure: Daily Sequential Organ Failure Assessment (SOFA) score Time: Until discharge or for a maximum of 14 days or readmissionDescription: NEWS is a tool which improves the detection and response to clinical deterioration in adult patients and is a key element of patient safety and improving patient outcomes
Measure: Daily National Early Warning Score (NEWS) 2 score Time: Until discharge or for a maximum of 14 days or readmissionDescription: its defined as patient discharge or a reduction of 2 points on a 6-point disease severity clinical scale
Measure: Clinical improvement Time: Until discharge or for a maximum of 14 days or readmissionDescription: Determination of the change in QT prolongation, before and after treatments as a measure of disease activity
Measure: QT prolongation Time: Until discharge or for a maximum of 14 days or readmissionDescription: Determination of the change in Cardiac arrythmia (fatal and non fatal), before and after treatments as a measure of disease activity
Measure: Cardiac arrythmia (fatal and non fatal) Time: Until discharge or for a maximum of 14 days or readmission11 Study on Safety and Efficacy of Favipiravir (Favipira) for COVID-19 Patient in Selected Hospitals of Bangladesh
A recent outbreak of coronavirus disease 2019 (COVID-19) caused by the novel coronavirus designated as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) started in Wuhan, China, at the end of 2019. The clinical characteristics of COVID-19 include respiratory symptoms, fever, cough, dyspnea, and pneumonia. As of 25 February 2020, at least 77 785 cases and 2666 deaths had been identified across China and in other countries; in particular, 977 and 861 cases were identified in South Korea and Japan, respectively. The outbreak has already caused global alarm. On 30 January 2020, the World Health Organization (WHO) declared that the outbreak of SARS-CoV-2 constituted a Public Health Emergency of International Concern (PHEIC), and issued advice in the form of temporary recommendations under the International Health Regulations (IHR).It has been revealed that SARS-CoV-2 has a genome sequence that is 75%-80% identical to that of SARS-CoV, and has more similarities to several bat coronaviruses. SARS-CoV-2 is the seventh reported human-infecting member of the family Coronaviridae, which also includes SARS-CoV and the Middle East respiratory syndrome (MERS)-CoV. It has been identified as the causative agent of COVID-19. Both the clinical and the epidemiological features of COVID-19 patients demonstrate that SARS-CoV-2 infection can lead to intensive care unit (ICU) admission and high mortality. About 16%-21% of people with the virus in China have become severely ill, with a 2%-3% mortality rate. However, there is no specific treatment against the new virus. Therefore, it is urgently necessary to identify effective antiviral agents to combat the disease and explore the clinical effect of antiviral drugs. One efficient approach to discover effective drugs is to test whether the existing antiviral drugs are effective in treating other related viral infections. Several drugs, such as ribavirin, interferon (IFN), Favipiravir (FPV), and Lopinavir (LPV)/ritonavir (RTV), have been used in patients with SARS or MERS, although the efficacy of some drugs remains controversial. It has recently been demonstrated that, as a prodrug, Favipiravir (half maximal effective concentration (EC50) = 61.88 μmol·L−1, half-maximal cytotoxic concentration (CC50) > 400 μmol·L−1, selectivity index (SI) > 6.46) effectively inhibits the SARS-CoV-2 infection in Vero E6 cells (ATCC-1586). Furthermore, other reports show that FPV is effective in protecting mice against Ebola virus challenge, although its EC50 value in Vero E6 cells was as high as 67 μmol·L−1. Therefore, clinical studies are urgently needed to evaluate the efficacy and safety of this antiviral nucleoside for COVID-19 treatment. After enrollment of the patients (day 1) depending on inclusion and exclusion criteria and laboratory findings confirming the presence of the COVID-19 virus, 25 patients will receive Favipiravir plus standard treatment and the second group of 25 patients will receive standard treatment only. The comparison of the findings of the follow up studies on days 4, 7, and 10 in terms of clinical manifestations, chest X-ray and laboratory findings, such as Real Time Polymerase Chain Reaction (RT-PCR) results for viral presence will determine whether Favipiravir has safety and efficacy against COVID-19 infections. All ethical issues related to this trial including right of the participants to withdraw from the study should be maintained according to of guidelines of International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP).
NCT04402203 COVID-19 Favipiravir (Favipira) Drug: Favipiravir Drug: Only Standard Treatment
Primary Outcomes
Description: Negative by RT-PCR for the virus at 4-10 days after initiation of therapy. However, negative results for the viral presence should be with an interval of at least 24 hours.
Measure: Number of participants negative by RT-PCR for the virus at 4-10 days after initiation of therapy. Time: at 4 to 10 days of therapyDescription: X-ray findings of lung condition improvement at Day-4, Day-7 and Day-10 of therapy
Measure: Number of participants with lung condition change assessed with X-ray. Time: at Day-4, Day-7 and Day-10 of therapySecondary Outcomes
Description: Clinical recovery indicates reduced duration of fever, cough, relief time auxiliary oxygen therapy or noninvasive mechanical ventilation rate.
Measure: Number of participants with clinical recovery Time: at Day-4, Day-7 and Day-10 of therapyMeasure: Number of participants with adverse effects of drug. Time: at Day-4, Day-7 and Day-10 of therapy
Measure: Number of participants requiring ICU admission Time: at Day-4, Day-7 and Day-10 of therapy
Measure: Number of death Time: at Day-4, Day-7 and Day-10 of therapy
12 A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Study Evaluating the Efficacy and Safety of Favipiravir in the Treatment of Adult Patients With COVID-19-Moderate Type
This is a multi-center, randomized, double-blind, placebo-controlled, phase III clinical study to evaluate the efficacy of Favipiravir combined with supportive care for adult patients with COVID-19-Moderate type.
NCT04425460 COVID-19 Drug: Favipiravir Other: Placebo
Primary Outcomes
Description: The duration from start of treatment (Favipiravir or placebo) to normalization of pyrexia, respiratory rate and SPO2 and relief of cough (where there are relevant abnormal symptoms at enrolment) that is maintained for at least 72h. Criteria for normalization or relief: Pyrexia (body temperature): axillary ≤37℃，or oral≤37.5℃，or rectal or tympanic ≤38℃; Respiratory rate: ≤24/min without oxygen inhalation; SPO2: >94% without oxygen inhalation; Cough: Subject-perceived improvement or resolution of cough.
Measure: Time from randomization to clinical recovery Time: 28 daysSecondary Outcomes
Description: Time from randomization to negativity in RT-PCR nucleic acid test for 2019-nCov within 28 days of randomization;
Measure: Negativity in RT-PCR nucleic acid test Time: 28 daysDescription: Time from randomization to resolution of pyrexia (defined the same as for the primary efficacy variable; applicable to subjects with pyrexia at enrolment) within 28 days of randomization;
Measure: Time from randomization to resolution of pyrexia Time: 28 daysDescription: Time from randomization to relief of cough (defined the same as for the primary efficacy variable; applicable to subjects with cough at enrolment) within 28 days of randomization; It is recommended that the severity of cough be graded as per NCI-CTCAE v5.0: Mild: Requires non-prescription treatment; Moderate: Requires medication treatment; limits instrumental activities of daily living; Severe: Limits self-care activities of daily living;
Measure: Time from randomization to relief of cough Time: 28 daysDescription: Incidence of deterioration/aggravation of pneumonia (defined as SPO2≤93% or PaO2/FiO2 ≤300 mmHg or distressed RR≥30/min without oxygen inhalation and requiring oxygen therapy or more advanced breath support) within 28 days of randomization;
Measure: Incidence of deterioration/aggravation of pneumonia Time: 28 daysDescription: Time from randomization to relief of dyspnoea (defined as subject-perceived improvement or resolution of dyspnoea; applicable to subjects with dyspnoea at enrolment) within 28 days of randomization;
Measure: Time from randomization to relief of dyspnoea Time: 28 daysDescription: Rate of auxiliary oxygen therapy or non-invasive ventilation within 28 days of randomization;
Measure: Rate of auxiliary oxygen therapy or non-invasive ventilation Time: 28 daysDescription: ICU admission rate within 28 days of randomization (except patients already enrolled in ICU which respect eligibility criteria);
Measure: ICU admission rate within 28 days of randomization Time: 28 daysDescription: All-cause mortality within 28 days of randomization.
Measure: All-cause mortality within 28 days of randomization. Time: 28 days13 An Adaptive, Multicenter, Randomized, Open-label, Comparative Clinical Study to Assess Efficacy and Safety of Favipiravir in Hospitalized Patients With COVID-19
The study is Phase II/III and consists of pilot and pivotal stages. The objective of the pilot stage is to conduct a preliminary assessment of the efficacy and safety of Favipiravir, and to select the optimal dosing regimen to study during the pivotal stage. The objective of the pivotal stage is to assess the efficacy and safety of Favipiravir compared with the Standard of care (SOC) in hospitalized patients with moderate to severe COVID-19 pneumonia.
NCT04434248 COVID-19 Drug: Favipiravir Drug: Standard of Care
Primary Outcomes
Description: Percent of patients with undetectable SARS-CoV-2 RNA level on Day 10
Measure: Rate of viral elimination by Day 10 [pilot stage, dose selection] Time: 10 DaysDescription: Median time to reach undetectable SARS-CoV-2 RNA level
Measure: Time to viral elimination [pivotal stage] Time: 28 DaysDescription: Median time reach clinical improvement (2 points of the Ordinal Scale for Clinical Improvement) or discharge from the hospital
Measure: Time to clinical improvement [pivotal stage] Time: 28 DaysSecondary Outcomes
Description: Percent of patients with undetectable SARS-CoV-2 RNA level
Measure: Rate of viral elimination Time: Days 3, 5, 7, 9, and 11Description: Median time [days] to reach normal levels of clinical indicators (body temperature, SpO2, breathing rate)
Measure: Time to normalization of clinical symptoms Time: 28 DaysDescription: Mean duration of oxygen therapy [days]
Measure: Duration of oxygen therapy Time: 28 DaysDescription: Change of lung damage level according to CT comparing to baseline [% of patients]
Measure: Change in the level of lung damage according to CT Time: Days 15, 22, and 29Description: Percent of patients transferred to the intensive care unit [% of patients]
Measure: Rate of transfer to the intensive care unit Time: 28 daysDescription: Percent of patients undergoing non-invasive lung ventilation [% of patients]
Measure: Rate of the use of non-invasive lung ventilation Time: 28 daysDescription: Percent of patients undergoing mechanical ventilation [% of patients]
Measure: Rate of the use of mechanical ventilation Time: 28 daysDescription: Percent of patients died within 28-days period [% of patients]
Measure: Mortality Time: 28 daysDescription: Determination of Cmax [ng/ml]
Measure: Peak plasma concentration (Cmax) Time: Day 1Description: Determination of Tmax [h]
Measure: Time to peak plasma concentration (Tmax) Time: Day 1Description: Determination of AUC0-t [ng*h/ml]
Measure: Area under the plasma concentration versus time curve (AUC0-t) Time: 10 daysDescription: Determination of Ctrough [ng/ml]
Measure: Trough plasma concentration (Ctrough) Time: 10 days14 An Adaptive Randomised Placebo Controlled Phase II Trial of Antivirals for COVID-19 Infection
This is a randomised placebo controlled phase II trial to examine the efficacy of antivirals to treat COVID-19 infection compared to placebo for virological cure and improved clinical outcomes. Individuals will be randomised to the candidate antiviral which in the first instance is Favipiravir or matched placebo and randomisation will be stratified according to whether the participant requires hospitalisation or not. This treatment will be given in addition to the usual standard of care in the participating hospital.
NCT04445467 COVID Drug: Favipiravir MeSH:Infection
Primary Outcomes
Description: Time to 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing
Measure: Time to virological cure Time: 14 daysSecondary Outcomes
Description: All adverse events definitely, probably or possibly related to study treatment.
Measure: Safety Time: 28 daysDescription: Time from randomization to an improvement of two points (from the status at randomization) on the 7-point ordinal scale
Measure: Clinical improvement Time: 28 daysDescription: Time from randomization to resolution of clinical symptoms (fever, cough, shortness of breath, cough). Resolution defined as the start of the first 24 hour period when all symptoms are rated as mild or absent and remained this way for 24 hours
Measure: Clinical symptoms Time: 28 daysDescription: Biomarkers taken as part of routine care including total lymphocyte count, CRP, Ferritin and LDH.
Measure: Biomarkers Time: 28 days15 Control of COVID-19 Outbreaks in Long Term Care (CONTROL-COVID)
To address the need to intervene to prevent the spread of COVID-19 in long-term care homes, we propose a randomized clinical trial of chemoprophylaxis in long-term care homes experiencing COVID-19 outbreaks. LTCH units experiencing an outbreak of COVID-19 will be randomized to chemoprophylaxis with favipiravir or placebo in a 1:1 ratio. Chemoprophylaxis in this setting refers to the use of favipiravir for pre-exposure prophylaxis, post-exposure prophylaxis, pre-emptive therapy, or treatment for established COVID-19. This design mimics the approach to influenza outbreaks, which has proven efficacy for outbreak control. The primary outcome will be control of the outbreak, defined as no new microbiologically confirmed case of COVID-19 for 24 consecutive days up to day 40.
NCT04448119 COVID-19 SARS-CoV-2 Drug: Favipiravir Drug: Favipiravir Placebo
Primary Outcomes
Description: Control of outbreak, defined as no new cases of COVID-19 in residents for 24 consecutive days up to day 40 after the start of prophylaxis
Measure: Control of Outbreak Time: Day 40Secondary Outcomes
Description: The proportion of residents of included LTCH units who die up to day 40, and up to day 60
Measure: Mortality (Residents) Time: Day 40, Day 60Description: The proportion of residents of included LTCH units who were uninfected at baseline and develop new symptomatic microbiologically confirmed COVID-19 up to day 40
Measure: COVID-19 Infection (Residents) Time: Day 40Description: The proportion of exposed staff uninfected at baseline in whom SARS-CoV-2 infection is identified up to day 14 and up to day 40
Measure: COVID-19 Infection (Staff) Time: Day 14, Day 40Description: The proportion of residents of included LTCH units hospitalized up to day 40
Measure: Hospitalization (Residents) Time: Day 40Description: The proportion of residents of included LTCH units who discontinue study medication due to adverse events
Measure: Medication Discontinuation (Residents) Time: Day 40Description: The proportion of LTCH staff of included LTCH units who discontinue study medication due to adverse events
Measure: Medication Discontinuation (Staff) Time: Day 40Description: The occurrence of new microbiologically confirmed COVID-19 infections in residents in other units of the LTCH up to day 40 (dichotomous, at LTCH level)
Measure: COVID-19 in new LTCH Units (a) Time: Day 40Description: The proportion of previously unaffected LTCH units of the remainder of the LTCH in which a case of COVID-19 is identified
Measure: COVID-19 in new LTCH Units (b) Time: Day 40Description: The proportion of residents in the remainder of the LTCH who develop COVID-19 infections up to day 40
Measure: COVID-19 in new LTCH Units (c) Time: Day 4016 A Trial of Favipiravir Therapy in Adults With Mild Coronavirus Disease COVID-19
Favipiravir is a selective and potent inhibitor of influenza viral RNA polymerase. It acts as a purine analogue, which selectively inhibits viral RNA-dependent RNA polymerase (RdRps). It has the characteristic of acting on RNA viruses including Ebola and Coronaviruses especially novel coronavirus (2019-nCoV). The purpose of this study is to evaluate the clinical efficacy and safety of Favipiravir in comparison to placebo in the treatment of mild COVID-19 cases. It is a Multicenter, randomized double-blinded, parallel-group trial.
NCT04464408 COVID-19 Drug: Favipiravir Drug: Placebo
Primary Outcomes
Description: Time from randomization to negativity in RT-PCR nucleic acid test for COVID-19 within 15 days of randomization
Measure: PCR negative Time: 15 daysSecondary Outcomes
Description: The duration from start of treatment (Favipiravir or placebo) to normalization of pyrexia, respiratory symptoms, and relief of cough (or other relevant symptoms at enrollment) that is maintained for at least 72 hours.
Measure: Time from randomization to clinical recovery Time: 15 daysMeasure: Symptoms progression based on clinical evaluation using simple scoring system. Time: 28 days
Measure: Rate of daily requirement of using antipyretics, analgesics, or antibiotics. Time: 15 days
Measure: 28 days mortality. Time: 28 days
Measure: Rate of requirement of hospitalization, ICU admission or Mechanical ventilation. Time: 28 days
Description: incidence of GI symptoms secondary to the study drug.
Measure: Incidence of Treatment-related Adverse Events [Safety and Tolerability] Time: 15 days17 An ObservationaI Study to Evaluate the Efficacy and Safety of Favipiravir in the Treatment of COVID-19 Patients Over 15 Years of Age Who Are Receiving Favipiravir
This study is an observational study (Non-interventional study) to evaluate the safety and efficacy of favipiravir in patients older than 15 years of age, diagnosed with COVID-19 and initiated treatment with favipiravir before enrollment to the study. Patients who have already had a routine favipiravir treatment decision or alternatively favipiravir treatment started at the time of enrollment, will be included in this study.
NCT04474457 COVID-19 Drug: Favipiravir
Primary Outcomes
Description: The evaluation of the recovery discharge until the 7th day of hospitalization after the initiation of treatment.
Measure: Time to recovery (discharge) Time: 7 daysDescription: The evaluation of decrease in viral load until 7th day hospitalization after the initiation of treatment.
Measure: Decrease in viral load Time: 7 daysSecondary Outcomes
Description: Number/characteristics of Adverse Event (AE), Serious Adverse Event (SAE) and discontinuation of treatment due to study drug from baseline until the end of study.
Measure: Adverse Event (AE), Serious Adverse Event (SAE) and discontinuation of treatment Time: 7 daysDescription: Clinical evaluation of occurrence of lymphopenia from baseline until the end of study.
Measure: Frequency of occurrence of lymphopenia from baseline Time: 7 daysDescription: Clinical evaluation of occurrence of thrombocytopenia from baseline until the end of study.
Measure: Frequency of occurrence of thrombocytopenia from baseline Time: 7 daysDescription: Clinical evaluation of ALT levels from baseline until the end of study.
Measure: Changes in alanine aminotransferase (ALT) levels from baseline Time: 7 daysDescription: Clinical evaluation of AST levels from baseline until the end of study.
Measure: Changes in aspartate aminotransferase (AST) levels from baseline Time: 7 daysDescription: Clinical evaluation of CRP levels from baseline until the end of study.
Measure: Changes in C-reactive protein (CRP) levels from baseline Time: 7 daysDescription: Clinical evaluation of D-dimer levels from baseline until the end of study.
Measure: Changes in level of D-dimer levels from baseline Time: 7 daysDescription: Clinical evaluation of PT values for blood to coagulate from baseline until the end of study.
Measure: Changes in prothrombin time (PT) values from baseline Time: 7 daysDescription: Clinical evaluation of PTT values for blood to coagulate from baseline until the end of study.
Measure: Changes in partial thromboplastin time (PTT) values from baseline Time: 7 daysDescription: Clinical evaluation of systolic and diastolic blood pressure levels from baseline until the end of study.
Measure: Changes in blood pressure from baseline Time: 7 daysDescription: Clinical evaluation of respiratory rate levels from baseline until the end of study.
Measure: Changes in respiratory rate from baseline Time: 7 daysDescription: Clinical evaluation of pulse oximetry levels from baseline until the end of study.
Measure: Changes in pulse oximetry from baseline Time: 7 daysDescription: Clinical evaluation of changes in fever from baseline until the end of study.
Measure: Changes in fever from baseline Time: 7 days18 Favipiravir, Lopinavir/Ritonavir or Combination Therapy: a Randomised, Double Blind, 2x2 Factorial Placebo-controlled Trial of Early Antiviral Therapy in COVID-19
The current pandemic of SARS-CoV-2 causing COVID-19 disease is an unprecedented global emergency. COVID-19 appears to be a disease with an early phase where the virus replicates, coinciding with first presentation of symptoms, followed by a later 'inflammatory' phase which results in severe disease in some individuals. It is known from other rapidly progressive infections such as sepsis and influenza that early treatment with antimicrobials is associated with better outcome. The trial will be conducted in key workers who are at high risk of acquiring SARS-CoV-2 infection and their household members. Apart from the risk of severe illness and death in the workers themselves and their household members, this phenomenon also impacts health system staffing levels. The objective of the FLARE trial is to assess whether early antiviral therapy with either favipiravir + Lopinavir/ritonavir (LPV/r), LPV/r or favipiravir is associated with a decrease in viral load compared with placebo.The hypothesis is that this holds for COVID-19 and that early antiviral treatment may prevent progression to the later phase of the disease.
NCT04499677 COVID-19 Drug: Favipiravir Drug: Lopinavir/ Ritonavir Other: Favipiravir Placebo Other: Lopinavir/ Ritonavir Placebo
Primary Outcomes
Description: Quantitative polymerase chain reaction (PCR) performed on saliva samples at Day 5 of therapy
Measure: Upper respiratory tract viral load at Day 5 Time: Day 5 from randomisationSecondary Outcomes
Description: Quantitative polymerase chain reaction (PCR) performed on saliva samples at Day 5 of therapy
Measure: Percentage of participants with undetectable upper respiratory tract viral load after 5 days of therapy Time: 5 days from randomisationDescription: Quantitative polymerase chain reaction (PCR) performed on stool samples at Day 7 and Day 14 post-randomisation
Measure: Proportion of participants with undetectable stool viral load after 7 days of therapy and 14 days post-randomisation Time: Day 7 and Day 14 from randomisationDescription: PCR performed on daily saliva samples collected between Day 1 and Day 7 post-randomisation
Measure: Rate of decrease in upper respiratory tract viral load during 7 days of therapy Time: 7 daysDescription: Daily body temperature records between Day 1 and Day 7 post-randomisation
Measure: Duration of fever following commencement of medication Time: 7 daysDescription: Standard diagnostic laboratory assays for liver transaminases, alkaline phosphatase and bilirubin
Measure: Proportion of participants with hepatotoxicity after 7 days of therapy and 14 days post-randomisation Time: Day 7 and Day 14 from randomisationDescription: Determination of medication-related adverse events by investigators at Day 7 and Day 14 post-randomisation
Measure: Proportion of participants with other medication-related toxicity after 7 days of therapy and 14 days post-randomisation Time: Day 7 and Day 14 from randomisationDescription: Participant self-report, review of hospital records and discharge summaries within 28 days of randomisation
Measure: Proportion of participants admitted to hospital with COVID-19 related illness Time: 28 daysDescription: Participant self-report, review of hospital records and discharge summaries within 28 days of randomisation
Measure: Proportion of participants admitted to ICU with COVID-19 related illness Time: 28 daysDescription: Participant self-report, review of hospital records and discharge summaries within 28 days of randomisation
Measure: Proportion of participants who have died with COVID-19 related illness Time: 28 daysDescription: Assess pharmacokinetics of favipiravir as measured by Clearance (CL)
Measure: Pharmacokinetics of favipiravir as measured by Clearance (CL) Time: Day 7 from randomisationDescription: Assess pharmacokinetics of favipiravir as measured by Volume of distribution (V)
Measure: Pharmacokinetics of favipiravir as measured by Volume of distribution (V) Time: Day 7 from randomisationDescription: Assess pharmacokinetics of favipiravir as measured by Absorption rate constant (Ka)
Measure: Pharmacokinetics of favipiravir as measured by Absorption rate constant (Ka) Time: Day 7 from randomisationDescription: Assess pharmacokinetics of favipiravir as measured by Maximum concentration (Cmax)
Measure: Pharmacokinetics of favipiravir as measured by Maximum concentration (Cmax) Time: Day 7 from randomisationDescription: Assess pharmacokinetics of favipiravir as measured by Time to maximum concentration (Tmax)
Measure: Pharmacokinetics of favipiravir as measured by Time to maximum concentration (Tmax) Time: Day 7 from randomisationDescription: Assess pharmacokinetics of favipiravir as measured by Elimination rate constant (Ke)
Measure: Pharmacokinetics of favipiravir as measured by Elimination rate constant (Ke) Time: Day 7 from randomisationDescription: Assess pharmacokinetics of favipiravir as measured by Area Under the Curve extrapolated to infinity (AUC (0-inf)
Measure: Pharmacokinetics of favipiravir as measured by Area Under the Curve extrapolated to infinity (AUC (0-inf) Time: Day 7 from randomisationDescription: Assess pharmacodynamics of favipiravir as measured by Rate of viral load decline (delta)
Measure: Pharmacodynamics of favipiravir as measured by Rate of viral load decline (delta) Time: Day 7 from randomisationDescription: Assess pharmacodynamics of favipiravir as measured by Maximum increase in viral load under drug treatment (Emax)
Measure: Pharmacodynamics of favipiravir as measured by Maximum increase in viral load under drug treatment (Emax) Time: Day 7 from randomisationDescription: Assess pharmacodynamics of favipiravir as measured by Concentration to achieve half the maximum possible effect (EC50)
Measure: Pharmacodynamics of favipiravir as measured by Concentration to achieve half the maximum possible effect (EC50) Time: Day 7 from randomisationDescription: Deep sequencing of virus and bioinformatic analysis
Measure: Proportion of participants with deleterious or resistance-conferring mutations in SARS-CoV-2 by Day 7 of treatment Time: Day 7 from randomisation19 Randomized Open-label Multicenter Parallel-group Study of Efficacy and Safety of TL-FVP-t vs. Standard of Care Therapy in Patients With Mild to Moderate Coronavirus Disease (SARS-CoV-2/COVID-19)
Randomized open-label multicenter parallel-group study of efficacy and safety of TL-FVP-t vs. standard of care therapy in patients with mild to moderate coronavirus disease (SARS-CoV-2/COVID-19)
NCT04501783 COVID-19 Drug: Favipiravir Drug: Standard of care (SOC) Drug: standard concomitant therapy
Primary Outcomes
Description: To determine the effect of TL-FVP-t vs. SOC on time to clinical improvement. The clinical improvement is defined as reduction on at least 1 score of patient clinical status according to WHO 8-category Ordinal Scale for Clinical Improvement compared to screening
Measure: Time to clinical improvement Time: through Day 28Description: To determine the effect of TL-FVP-t vs. SOC on time to viral clearance of SARS-CoV-2 virus as measured by PCR in oropharyngeal sampling
Measure: Time to viral clearance Time: through Day 28Secondary Outcomes
Description: To determine the effect of TL-FVP-t vs. SOC on proportion of subjects (%) with clinical improvement according to WHO 8-category Ordinal Scale for Clinical Improvement
Measure: Rate of clinical improvement at separate time points Time: Day 7Description: To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with viral clearance of SARS-CoV-2 virus as measured by PCR in oropharyngeal sampling at separate time points
Measure: Rate of viral clearance at separate time points Time: Days 5 and 7Description: To determine the effect of TL-FVP-t vs. SOC on time to body temperature normalization determined as body temperature < 37°C without antipyretics for at least 48 hours.
Measure: Time to body temperature normalization Time: through Day 28Description: To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with resolution of lung changes on CT
Measure: Rate of resolution of lung changes on CT Time: Day 14Description: To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with ADR and serious ADR
Measure: Rate of adverse drug reactions (ADR) and serious ADR Time: through Day 28Description: To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with severe ADR
Measure: Rate of severe ADR Time: through Day 28Description: To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) discontinued therapy due ADR
Measure: Rate therapy termination due to ADR Time: through Day 28