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IRCT20201005048936N1 IRCT 2020-10-26 Dr. Abidi pharmacutical Co. The evaluation of efficacy of Favipiravir in patients with mild to moderate COVID-19 The evaluation of safety and efficacy of Favipiravir (ABIDI Pharmaceutical Co, Iran) to shorten the contagiousness in patients with mild to moderate COVID-19 2020-10-31 anticipated 126 Complete https://irct.ir/trial/51499 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Stratified randomization depending on recruitment centers will be undertaken. Accordingly, the number of recruited patients would be equal in three recruitment centers. In each center, patients will be equally allocated to study groups, through the simple randomisation method. Random sequence will be produced by using the random generation, available at www.sealedenvelope.com. In doing so, for two study group and total sample size of 126, three block with 42 block size will be defined. Through this method, it will ensured that an equal number of participants in each recruitment center will be obtained. There is no concealment over the randomization process. 3 COVID-19. Intervention 1: Intervention group:Favipiravir administered orally, produced by the Dr. Abidi pharmacutical Co, Iran, 3200mg (1600/ bid) on the first day followed by 1200mg (600mg/bid) daily for the next 4 days (days 1-5). Intervention 2: Control group: Hydroxichloroqune (produced by any pharmacutical company in Iran), administered orally, 400mg (bid) on the first day followed by 200mg/bid/day for the next 4 days (days 1-5) with or without Naproxen and with or without Azythromycin. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Ayat Ahmadi
Unit 23; No.1547; Nth Kargar str.
Tehran Iran (Islamic Republic of) 1417993357 +98 21 8896 3546 ayat1049@gmail.com Tehran University of Medical Sciences scientific Ayat Ahmadi
Unit 23; No.1547; Nth Kargar str.
Tehran Iran (Islamic Republic of) 1417993357 +98 21 8896 3546 aahmadis@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with mild to moderate COVID-19 symptoms (According to the national guidance definitions) with positive PCR test for COVID-19 At least 18 years old Less than 10 days from the onset of symptoms 18 years no limit Both History of liver disorders (specifically active liver disorders and liver dysfunction included: ALT/AST > 1.5 ULN and ALP > 2.5 ULN and total Bilirubin>1.25 ULN) Allergy to Favipiravir or its ingredients Pregnancy and lactation History of gastrointestinal(GI) disorders such as GI bleeding or GI inflammatory diseases or history of GI surgery that intervene in the Favipiravir absorption process History of active or latent tuberculosis Active infection other than COVID-19 Abnormal metabolism of uric acid/ Gout Abnormal test results in the screening stage that need more clinical assessments Participation in any type of clinical trials in the last 30 days Any psychological disorders that affects patient compliance of the study protocol Any disease or disorder that investigators believed might put participants in an excess risk, if they were included or history of allergy to any antiviral nocleoside-analog drugs with viral RNA polymerase inhibition mechanism Active HBV, HCV HIV or any other known immunological disorders or using immunosuppressive drugs U07.1 COVID-19 Treatment - Drugs Treatment - Drugs Intervention group:Favipiravir administered orally, produced by the Dr. Abidi pharmacutical Co, Iran, 3200mg (1600/ bid) on the first day followed by 1200mg (600mg/bid) daily for the next 4 days (days 1-5) Control group: Hydroxichloroqune (produced by any pharmacutical company in Iran), administered orally, 400mg (bid) on the first day followed by 200mg/bid/day for the next 4 days (days 1-5) with or without Naproxen and with or without Azythromycin Turning PCR test result into negative. Timepoint: The 6th day and the 14th day after the intervention commence. Method of measurement: Laboratory PCR test for diagnosis of COVID-19. Time to recovery of symptoms(fever and cough). Timepoint: up to 14 days after the intervention commence. Method of measurement: telephone call examination. Symptoms recovery(fever and cough). Timepoint: day 6, day 14 and day 28 after the intervention commence. Method of measurement: telephone call examination. Incidence of adverse events and adverse reactions. Timepoint: up to the 28th day of follow up. Method of measurement: telephone call examination and/or lab tests. ICU admission. Timepoint: up to 28 days after the commence of the intervention. Method of measurement: telephone call follow up. Mortality. Timepoint: up to 28 days after the commence of the intervention. Method of measurement: telephone calls follow up. Dr. Abidi pharmacutical Co. Approved 2020-09-30 Ethics committee of Imam khomeni hospital in Tehran University of Medical Sciences Imam Khomeini Hospital Complex, Tohid Square Tehran Tehran Iran (Islamic Republic of)