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Completed

NCT Number: NCT04338698

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

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).

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Key information

Conditions

COVID 19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nawaz Sharif Medical College, Dhok Gujra, Pakistan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Hydroxychloroquine

Drug

Hydroxychloroquine Sulfate (200 mg orally thrice a day for 5 days)

oseltamivir

Drug

Oseltamivir (75 mg orally twice a day for 5 days)

Azithromycin

Drug

Azithromycin (500 mg orally once a day on day 1, followed by 250 mg orally daily on days 2-5)

Primary outcomes

  1. Laboratory Result

    Time frame: Day 07 on follow-up

    The laboratory-based primary outcome will be turning test negative for COVID-19 on RT-qPCR calculated as viral load of < 150 i.u

  2. Clinical Outcome

    Time frame: Day 07 on follow-up

    The clinical primary outcome will be improvement of two points on a seven-category ordinal scale shown below:

    • Not hospitalized, able to resume normal activities
    • Not hospitalized, but unable to resume normal activities
    • Hospitalization, not requiring supplemental oxygen
    • Hospitalization, requiring supplemental oxygen
    • Hospitalization, requiring noninvasive mechanical ventilation
    • Hospitalization, requiring invasive mechanical ventilation
    • Death

Sponsors and collaborators

Lead sponsor

Shehnoor Azhar

Other

Registry information

Official study title

Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment

Acronym: PROTECT

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 8, 2020
Registry last updated
Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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