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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 : 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

Tracking Information
First Submitted Date  ICMJE April 4, 2020
First Posted Date  ICMJE April 8, 2020
Last Update Posted Date July 15, 2020
Actual Study Start Date  ICMJE April 22, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2020)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2020)
  • 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
  • Clinical Outcome [ Time Frame: Day 07 on follow-up ]
    The clinical primary outcome will improvement of two points on a seven-category ordinal scale
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hydroxychloroquine, Oseltamivir and Azithromycin for the Treatment of COVID-19 Infection: An RCT
Official Title  ICMJE Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE COVID 19
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Active Comparator: Control Intervention
    Hydroxychloroquine
    Intervention: Drug: Hydroxychloroquine
  • Experimental: Comparator 1
    Azithromycin
    Intervention: Drug: Azithromycin
  • Experimental: Comparator 2
    Oseltamivir
    Intervention: Drug: Oseltamivir
  • Experimental: Comparator 3
    Hydroxychloroquine + Azithromycin
    Interventions:
    • Drug: Hydroxychloroquine
    • Drug: Azithromycin
  • Experimental: Comparator 4
    Hydroxychloroquine + Oseltamivir
    Interventions:
    • Drug: Hydroxychloroquine
    • Drug: Oseltamivir
  • Experimental: Comparator 5
    Oseltamivir + Azithromycin
    Interventions:
    • Drug: Oseltamivir
    • Drug: Azithromycin
  • Experimental: Comparator 6
    Hydroxyquinine + Oseltamivir + Azithromycin
    Interventions:
    • Drug: Hydroxychloroquine
    • Drug: Oseltamivir
    • Drug: Azithromycin
  • No Intervention: Observational Cohort
    Non-consenting to randomization
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 4, 2020)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shehnoor Azhar, MPH +92 321 4090221 shehnoor.azhar@gmail.com
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04338698
Other Study ID Numbers  ICMJE 12(06)/2016-Coord
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Shehnoor Azhar, University of Health Sciences Lahore
Study Sponsor  ICMJE Shehnoor Azhar
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Javed Akram, FRCP University of Health Sciences Lahore
PRS Account University of Health Sciences Lahore
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP