Trial NCT04333589
Publication Zhao H, Int Immunopharmacol, 2021 (published paper)
Dates: 2020-03-27 to 2020-05-09
Funding: Public/non profit (Chinese COVID-19 scientific research emergency; China Mega-Project for Infectious Diseases; China Mega-Project for Innovative Drugs)
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Multicenter / China Follow-up duration (days): 30 | |
Inclusion criteria | Over 18 years of age; both male and female; After the first diagnosis and treatment of COVID-19, the SARS-CoV-2 RNA test of respiratory specimens such as sputum or nasopharyngeal swabs, has been negative for two consecutive times (sampling time interval of at least 24 h), in accordance with China COVID-19 guidelines (7th Edition), discharged; During screening visit (follow-up after discharge), the SARS-CoV-2 RNA test of COVID-19 is positive in any one of the following samples: sputum, nasopharyngeal swabs, blood, feces or other specimens. Regardless of whether or not they had symptoms and the severity of symptoms; Volunteer to participate in the research and sign the Informed Consent Form. |
Exclusion criteria | Allergic to favipiravir; Pregnant or lactating women; The researchers considered the patient was not suitable to participate in this clinical trial. |
Interventions | |
Treatment
Favipiravir Initial dose: 1600 mg twice a day orally on day 1 -Maintenance dose: 600 mg twice a day orally on days 2-7. Day 8-14 according to clinician's judgement, but no more than 14 days of treatment. |
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Control
Standard care ( / ) Definition of Standard care: Oxygen therapy, drugs that reduced phlegm and relieve cough, including thymosin, proprietary Chinese medicine, etc. | |
Participants | |
Randomized 55 participants (n1=36 / n2= 19) | |
Characteristics of participants N=55 Mean age : 55.7 25 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=0 | |
Primary outcome | |
In the register Viral nucleic acid test negative conversion rate [ Time Frame: 5 months ] | |
In the report The primary outcome was time to achieve a consecutive twice (at intervals of more than 24 h) negative RT-PCR result for SARS-CoV-2 RNA in nasopharyngeal swab and sputum sample. | |
Documents available |
Protocol Yes. In English Statistical plan NR Data-sharing stated
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Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
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General comment |