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Study on Safety and Efficacy of Favipiravir (Favipira) for COVID-19 Patient in Selected Hospitals of Bangladesh

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ClinicalTrials.gov Identifier: NCT04402203
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
Bangladesh Medical Research Council (BMRC)

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
COVID-19 Favipiravir (Favipira) Drug: Favipiravir Drug: Only Standard Treatment Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, placebo-controlled randomized control study. Randomization will be done by computerized randomization table Group A Patient (25) = Favipiravir + Standard Treatment Group B Patient (25) = Only Standard Treatment For better result sample size may be multiply on the basis of availability of COVID-19 patient in the study hospital.
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Study on Safety and Efficacy of Favipiravir (Favipira) for COVID-19 Patient in Selected Hospitals of Bangladesh
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Favipiravir + Standard Treatment
Favipiravir 200 mg (Favipira) tablet will be given orally. Day 1: Tablet Favipiravir 1600 mg twice daily Days 2-Days 10: Tablet Favipiravir 600 mg twice daily.
Drug: Favipiravir
Favipiravir 200 mg (Favipira) tablet will be given orally. Day 1: Tablet Favipiravir 1600 mg twice daily Days 2-Days 10: Tablet Favipiravir 600 mg twice daily.

Placebo Comparator: Only Standard Treatment
Standard treatment included oxygen inhalation, oral or intravenous rehydration, electrolyte correction, antipyretics, analgesics, antibiotics and antiemetic drugs & the medication any patient is on due to any concomitant diseases.
Drug: Only Standard Treatment
Standard treatment included oxygen inhalation, oral or intravenous rehydration, electrolyte correction, antipyretics, analgesics, antibiotics and antiemetic drugs & the medication any patient is on due to any concomitant diseases.




Primary Outcome Measures :
  1. Number of participants negative by RT-PCR for the virus at 4-10 days after initiation of therapy. [ Time Frame: at 4 to 10 days of therapy ]
    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.

  2. Number of participants with lung condition change assessed with X-ray. [ Time Frame: at Day-4, Day-7 and Day-10 of therapy ]
    X-ray findings of lung condition improvement at Day-4, Day-7 and Day-10 of therapy


Secondary Outcome Measures :
  1. Number of participants with clinical recovery [ Time Frame: at Day-4, Day-7 and Day-10 of therapy ]
    Clinical recovery indicates reduced duration of fever, cough, relief time auxiliary oxygen therapy or noninvasive mechanical ventilation rate.

  2. Number of participants with adverse effects of drug. [ Time Frame: at Day-4, Day-7 and Day-10 of therapy ]
  3. Number of participants requiring ICU admission [ Time Frame: at Day-4, Day-7 and Day-10 of therapy ]
  4. Number of death [ Time Frame: at Day-4, Day-7 and Day-10 of therapy ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: Male or female patients 18 -65 years old
  2. Respiratory samples tested positive for the novel coronavirus.
  3. Initial symptoms will within 7 days
  4. Nonpregnant women (confirmed by urine human chorionic gonadotropin (HCG) test prior to enrollment)

Exclusion Criteria:

  1. Severe clinical condition (meeting one of the following criteria: a resting respiratory rate greater than 30 per minute, oxygen saturation below 93%, oxygenation index (OI) < 300 mmHg (1 mmHg = 133.3 Pa), respiratory failure, shock, and/or combined failure of other organs that required ICU monitoring and treatment).
  2. Chronic liver and kidney disease and reaching end stage. (Serum aspartate aminotransferase (AST) and Serum alanine aminotransferase (ALT) will be elevated over 5 times of normal upper range will excluded).

    (Normal upper limit of Serum AST = 40 units /L, ALT = 56 units /L)

  3. Serum uric acid >7.0 mg/dL in Male and Serum uric acid >6.0 mg/dL in Female will excluded
  4. ICU patient
  5. Previous history of allergic reactions to Favipiravir.
  6. Pregnant or lactating women
  7. Women of a childbearing age with a positive pregnancy test.
  8. Miscarriage, or within 2 weeks after delivery
  9. Hypertensive patients, who are taking Calcium Channel Blockers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04402203


Contacts
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Contact: Ahmedul Kabir, MBBS, FCPS, FACP, FRCP +88 01720910541 ahmedul_986@yahoo.com

Locations
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Bangladesh
Mahanagar General Hospital, Dhaka (Site-1), Mugda Medical College Hospital, Dhaka (Site-2), Kurmitola General Hospital, Dhaka (Site-3), Dhaka Medical College Hospital, Dhaka (Site-4) Recruiting
Dhaka, Bangladesh
Contact: Ahmedul Kabir, MBBS, FCPS FACP, FRCP    +88 01720910541    ahmedul_986@yahoo.com   
Contact: Md. Billal Alam, MBBS, FCPS MD, MACP, FACP    +88 01716210121    profbillal66@gmail.com   
Sponsors and Collaborators
Bangladesh Medical Research Council (BMRC)
Additional Information:
Publications:

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Responsible Party: Bangladesh Medical Research Council (BMRC)
ClinicalTrials.gov Identifier: NCT04402203    
Other Study ID Numbers: 29318042020
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No