Hydroxychloroquine, Oseltamivir and Azithromycin for the Treatment of COVID-19 Infection: An RCT

Last updated: January 27, 2022
Sponsor: Shehnoor Azhar
Overall Status: Completed

Phase

3

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT04338698
12(06)/2016-Coord
  • Ages > 18
  • All Genders

Study Summary

To evaluate the effectiveness of Hydroxychloroquine Sulfate (200 mg orally 8hr thrice a day for 5 days) vs oseltamivir (75 mg orally twice a day for 5 days) vs Azithromycin (500 mg orally daily on day 1, followed by 250 mg orally twice a day on days 2-5) alone and in combination (in all seven groups), in clearing the coronavirus nucleic acid from throat and nasal swab and in bringing about clinical improvement on day 7 of follow-up (primary outcomes).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Confirmed SARS-CoV-2 (COVID-19) infection by a positive test result
  2. Either gender
  3. Symptomatic for example fever, dry Cough, difficulty to breathe

Exclusion

Exclusion Criteria:

  1. Confirmed absence of SARS-CoV-2 (COVID-19) infection by a negative test result
  2. Have chronic conditions such as heart disease, liver and kidney failure
  3. Pregnant or currently lactating
  4. Immunocompromise and/or systemic disease(s)
  5. On other antiviral drugs
  6. History of allergy to any of the drugs to be administered in this study

Study Design

Total Participants: 550
Study Start date:
April 22, 2020
Estimated Completion Date:
November 22, 2020

Study Description

A scientific taskforce notified by the Ministry of Science and Technology of the Government of Pakistan will oversee a comprehensive cohort study. Within this cohort, a multicenter, adaptive, randomized controlled trial will evaluate, among eligible SARS-Cov-2 (COVID-19) infected patients receiving standard supportive care who consent to randomization following a new diagnosis in Pakistan, if Hydroxychloroquine Sulfate alone (control intervention) vs a series of alternatives (comparator interventions) including Oseltamivir and Azithromycin alone and in combination with Hydroxychloroquine Sulfate is effective in clearing the coronavirus and improving the clinical course of the disease. Those not consenting to randomization will be followed up for outcomes of SARS-Cov-2 infection with supportive care only. Findings of this study are expected to inform clinical care and public health protocols and policies for management of SARS-Cov-2.

Connect with a study center

  • Faislabad Medical University

    Faisalābad,
    Pakistan

    Site Not Available

  • Gujranwala Medical College

    Gujrānwāla,
    Pakistan

    Site Not Available

  • Nawaz Sharif Medical College

    Gujrāt,
    Pakistan

    Site Not Available

  • Szabmu-Pims

    Islamabad,
    Pakistan

    Site Not Available

  • Akram Medical Complex

    Lahore,
    Pakistan

    Site Not Available

  • Fatima Jinnah Medical University

    Lahore,
    Pakistan

    Site Not Available

  • King Edward Medical University-Mayo Hospital

    Lahore,
    Pakistan

    Site Not Available

  • Lahore General Hospital

    Lahore,
    Pakistan

    Site Not Available

  • Khyber Teaching Hospital

    Peshawar,
    Pakistan

    Site Not Available

  • Rawalpindi Medical University

    Rawalpindi,
    Pakistan

    Site Not Available

  • Sargodha Medical College

    Sargodha,
    Pakistan

    Site Not Available

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