Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04338698
Recruitment Status : Recruiting
First Posted : April 8, 2020
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Shehnoor Azhar, University of Health Sciences Lahore

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Actual Study Start Date : April 22, 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Shehnoor Azhar, MPH +92 321 4090221 shehnoor.azhar@gmail.com

Locations
Layout table for location information
Pakistan
Faislabad Medical University Recruiting
Faisalābad, Pakistan
Contact: Hanif Nagra         
Gujranwala Medical College Recruiting
Gujrānwāla, Pakistan
Contact: Maroof Aziz         
Nawaz Sharif Medical College Recruiting
Gujrāt, Pakistan
Szabmu-Pims Recruiting
Islamabad, Pakistan
Contact: Tanweer Khaliq         
Akram Medical Complex Recruiting
Lahore, Pakistan
Contact: Shehla Javed         
Fatima Jinnah Medical University Recruiting
Lahore, Pakistan
Contact: Aamir Zaman         
King Edward Medical University-Mayo Hospital Recruiting
Lahore, Pakistan
Contact: Khalid M Gondal         
Lahore General Hospital Recruiting
Lahore, Pakistan
Contact: Farah Sadiq         
Khyber Teaching Hospital Recruiting
Peshawar, Pakistan
Contact: Saadia Ashraf         
Rawalpindi Medical University Recruiting
Rawalpindi, Pakistan
Contact: Muhammad Umar         
Sargodha Medical College Recruiting
Sargodha, Pakistan
Contact: Saifullah Goraya         
Sponsors and Collaborators
Shehnoor Azhar
Investigators
Layout table for investigator information
Principal Investigator: Javed Akram, FRCP University of Health Sciences Lahore
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
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: July 15, 2020
Last Verified: July 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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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