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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04338698
Recruitment Status : Completed
First Posted : April 8, 2020
Last Update Posted : February 10, 2022
Sponsor:
Information provided by (Responsible Party):
Shehnoor Azhar, University of Health Sciences Lahore

Brief 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).

Condition or disease Intervention/treatment Phase
COVID 19 Drug: Hydroxychloroquine Drug: Oseltamivir Drug: Azithromycin Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Adaptive design (sample size given below is indicative)
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment
Actual Study Start Date : April 22, 2020
Actual Primary Completion Date : November 15, 2020
Actual Study Completion Date : November 22, 2020


Arm Intervention/treatment
Active Comparator: Control Intervention
Hydroxychloroquine
Drug: Hydroxychloroquine
Hydroxychloroquine Sulfate (200 mg orally thrice a day for 5 days)

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

Experimental: Comparator 2
Oseltamivir
Drug: Oseltamivir
Oseltamivir (75 mg orally twice a day for 5 days)

Experimental: Comparator 3
Hydroxychloroquine + Azithromycin
Drug: Hydroxychloroquine
Hydroxychloroquine Sulfate (200 mg orally thrice a day for 5 days)

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

Experimental: Comparator 4
Hydroxychloroquine + Oseltamivir
Drug: Hydroxychloroquine
Hydroxychloroquine Sulfate (200 mg orally thrice a day for 5 days)

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

Experimental: Comparator 5
Oseltamivir + Azithromycin
Drug: Oseltamivir
Oseltamivir (75 mg orally twice a day for 5 days)

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

Experimental: Comparator 6
Hydroxyquinine + Oseltamivir + Azithromycin
Drug: Hydroxychloroquine
Hydroxychloroquine Sulfate (200 mg orally thrice a day for 5 days)

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

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

No Intervention: Observational Cohort
Non-consenting to randomization



Primary Outcome Measures :
  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:

    1. Not hospitalized, able to resume normal activities
    2. Not hospitalized, but unable to resume normal activities
    3. Hospitalization, not requiring supplemental oxygen
    4. Hospitalization, requiring supplemental oxygen
    5. Hospitalization, requiring noninvasive mechanical ventilation
    6. Hospitalization, requiring invasive mechanical ventilation
    7. Death



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

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 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

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): NCT04338698


Locations
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Pakistan
Faislabad Medical University
Faisalābad, Pakistan
Gujranwala Medical College
Gujrānwāla, Pakistan
Nawaz Sharif Medical College
Gujrāt, Pakistan
Szabmu-Pims
Islamabad, Pakistan
Akram Medical Complex
Lahore, Pakistan
Fatima Jinnah Medical University
Lahore, Pakistan
King Edward Medical University-Mayo Hospital
Lahore, Pakistan
Lahore General Hospital
Lahore, Pakistan
Khyber Teaching Hospital
Peshawar, Pakistan
Rawalpindi Medical University
Rawalpindi, Pakistan
Sargodha Medical College
Sargodha, Pakistan
Sponsors and Collaborators
Shehnoor Azhar
Investigators
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Principal Investigator: Javed Akram, FRCP University of Health Sciences Lahore
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shehnoor Azhar, Study Coordinator, University of Health Sciences Lahore
ClinicalTrials.gov Identifier: NCT04338698    
Other Study ID Numbers: 12(06)/2016-Coord
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: On completion of study, investigators are open to participation in planned IPD projects with a prospective registration, subject to appropriate approvals

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Azithromycin
Hydroxychloroquine
Oseltamivir
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Antiviral Agents