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

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ClinicalTrials.gov Identifier: NCT04338698
Recruitment Status : Not yet recruiting
First Posted : April 8, 2020
Last Update Posted : April 10, 2020
Sponsor:
Collaborator:
Federal Task Force on Science & Technology notified by Government of Pakistan
Information provided by (Responsible Party):
Shehnoor Azhar, University of Health Sciences Lahore

Study Description
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Brief Summary:
To evaluate the effectiveness of Hydroxychloroquine Phosphate/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 Phosphate/Sulfate alone (control intervention) vs a series of alternatives (comparator interventions) including Oseltamivir and Azithromycin alone and in combination with Hydroxychloroquine Phosphate/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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 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
Estimated Study Start Date : April 7, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control Intervention
Hydroxychloroquine
 Drug: Hydroxychloroquine
Hydroxychloroquine Phosphate/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 Phosphate/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 Phosphate/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 Phosphate/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


Outcome Measures
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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


Eligibility Criteria
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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
Contacts and Locations
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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


Contacts
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Contact: Shehnoor Azhar, MPH +92 321 4090221 shehnoor.azhar@gmail.com

Sponsors and Collaborators
Shehnoor Azhar
Federal Task Force on Science & Technology notified by Government of Pakistan
Investigators
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Principal Investigator: Javed Akram, FRCP University of Health Sciences Lahore
More Information
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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: April 10, 2020
Last Verified: April 2020
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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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