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IRCT20150808023559N23 IRCT 2020-10-11 Ardabil University of Medical Sciences Effectiveness of favipiravir in comparison with Tenofovir Alafenamid in patients with COVID-19 Evaluation of safety and effectiveness of favipiravir in comparison with Tenofovir Alafenamid in hospitalized patients with COVID-19 2020-09-20 anticipated 100 Complete https://irct.ir/trial/50405 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method is a simple randomizing using a table of random numbers, a set of numbers which is completely generated randomly without any specific pattern or order in a table form. Table numbers are read from the left, in a way that even numbers are assgined to intervention A and odd numbers to intervention B. In this way, the researcher touches one of the numbers and moves to the right, then records the numbers and assigns them to different groups. Next, considering the volume of the research sample, aluminum wrapper envelopes are prepared (in order not to clarify the content of the envelopes), each of the random sequences is recorded on a card and placed inside an envelope.To maintain a random sequence, envelopes are numbered in the same way. Finally, the flap of the envelopes are sealed and respectively placed inside a box. To reveal the participants' assigned group, at the beginning of the registration based on the order of eligible participants entry to study, one of the envelopes is opened. 2 COVID-19. Intervention 1: Intervention group: Group receiving Favipiravir. This group will receive stat dose of eight 200 mg Favipiravir tablets(Nafas farmed Co, Iran) followed by Favipiravir 600 mg three times a day for 7 days. This regimen could be continued for 10 days if necessary according to clinical response of the patient. Intervention 2: Control group: will receive Tenofovir alafenamid (Bakhtar bioshimi Co, Iran) 25 mg for 7 days. 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 Study results are not yet clear
public Somaieh Matin
Imam Khomeini Hospital, Shahid Jeddi street, Ardabil
Ardabil Iran (Islamic Republic of) 53141 56198 +98 45 3325 1410 s.matin@arums.ac.ir Ardabil University of Medical Sciences scientific Somaieh Matin
Imam Khomeini Hospital, Shahid Jeddi street, Ardabil
Ardabil Iran (Islamic Republic of) 5314156198 +98 45 3325 1410 s.matin@arums.ac.ir Ardabil University of Medical Sciences Iran (Islamic Republic of) Diagnosis of COVID-19 based on chest CT scan or positive PCR test for COVID-19 Requiring hospitalization Patient's age between 16 and 100 years Signing informed consent form 16 years 100 years Both Receiving other antiviral medicationsrenal failure Pregnancy HIV Lactation Renal failure U07.1 COVID-19 Treatment - Drugs Treatment - Drugs Intervention group: Group receiving Favipiravir. This group will receive stat dose of eight 200 mg Favipiravir tablets(Nafas farmed Co, Iran) followed by Favipiravir 600 mg three times a day for 7 days. This regimen could be continued for 10 days if necessary according to clinical response of the patient. Control group: will receive Tenofovir alafenamid (Bakhtar bioshimi Co, Iran) 25 mg for 7 days. Hospital mortality. Timepoint: Up to two weeks after the intervention on a daily basis. Method of measurement: Patient medical records. Duration of hospitalization. Timepoint: From the time of hospitalization to the patient's discharge from the hospital. Method of measurement: Patient medical records. Ardabil University of Medical Sciences Approved 2020-04-11 Ethics committee of Ardabil University of Medical Sciences Ardabil University of Medicine Sciences, Daneshgah street, Ardabil Ardabil Ardabil Iran (Islamic Republic of)