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Clearing the Fog: Is Hydroxychloroquine Effective in Reducing COVID-19 Progression (COVID-19)

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: NCT04491994
Recruitment Status : Completed
First Posted : July 30, 2020
Results First Posted : August 21, 2020
Last Update Posted : August 21, 2020
Sponsor:
Collaborator:
Pak Emirates Military Hospital Rawalpindi, Pakistan
Information provided by (Responsible Party):
sultan mehmood kamran, UNICEF

Brief Summary:

Brief Summary: Purpose of this study is to evaluate efficacy of hydroxychloroquine (HCQ) in reducing progression of Corona Virus Disease 2019 (COVID - 19) and achieving viral clearance.

Condition or disease :I COVID-19 ntervention/treatment :Drug: Hydroxychloroquine Sulfate Phase: Phase III


Condition or disease Intervention/treatment Phase
Covid19 Progression Drug: HCQ Phase 3

Detailed Description:

This study explores efficacy of HCQ (400mg BD on D0 and 200mg BD D1-D5) in reducing progression of Mild Covid-19 patients and decreasing viral load.

Participants of study will be randomized 2:1 to receive either Active drug or standard of care (SOC) treatment respectively. We aim to demonstrate reduced COVID-19 progression and early viral clearance in individuals on HCQ therapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization rules were designed by Dr. Wasim Alamgir together with principal investigators and implemented by an independent statistician who was not involved in data analysis. Stratified random sampling was applied to stratify all eligible patients according to age, gender and comorbidities. Computerized random number generator was used and allocation was done in 2:1 sequence. Cards with each group assignment number randomly generated by computer were placed in sequentially numbered envelopes that were opened as the patients were enrolled
Masking: None (Open Label)
Masking Description: Neither patients, nor investigators, nor statisticians were masked to treatment assignment. Lab staff who performed sampling for PCR, basic blood tests and other routine measurement were unaware of treatment information.
Primary Purpose: Treatment
Official Title: Clearing the Fog: Is HCQ Effective in Reducing COVID-19 progression-a Randomized Controlled Trial
Actual Study Start Date : April 10, 2020
Actual Primary Completion Date : May 31, 2020
Actual Study Completion Date : May 31, 2020

Arm Intervention/treatment
No Intervention: Standard of Care (SOC)
Patients selected in supportive arm will be given daily standard doses of oral Vit C (2g), Vit D (alfacalcidiol 1µg), Zinc (50mg) and paracetamol (as required).
Experimental: HCQ arm
Patients selected in experimental arm will be given Tab HCQ (400mg BD on D0 followed by 200mg BD D1-D5) in addition to supportive treatment
Drug: HCQ
Tab HCQ 400mg 12 hourly day 0 followed by tab HCQ 200mg 12 hrly for next 5 days
Other Name: HCQ + Standard of Care (SOC)




Primary Outcome Measures :
  1. Number of Participants With Progression [ Time Frame: 5 days ]
    After start of treatment, development of fever > 101 F for > 72 hours, shortness of breath by minimal exertion (10-Step walk test), derangement of basic lab parameters (ALC < 1000 or raised CRP) or appearance of infiltrates on CXR during course of treatment was labeled as progression irrespective of PCR status


Secondary Outcome Measures :
  1. Viral Clearance [ Time Frame: 14 days ]
    PCR negativity on day 7 and 14 after admission



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild Corona virus disease (COVID-19)
  • PCR confirmed infection
  • Hospital admitted patients

Exclusion Criteria:

  • Moderate, severe and critical COVID-19
  • day 0 CRP greater than 6mg/dl, ALC < 1000 or evidence of infiltrates on X-ray chest
  • comorbidity with life expectancy less than 6 months
  • Contraindications to HCQ therapy

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): NCT04491994


Locations
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Pakistan
Pak Emirates Military Hospital
Rawalpindi, Punjab, Pakistan, 46000
Sponsors and Collaborators
UNICEF
Pak Emirates Military Hospital Rawalpindi, Pakistan
Investigators
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Study Director: Imran m Fazal, FCPS Pak Emirates Military Hospital (PEMH) Rawalpindi
  Study Documents (Full-Text)

Documents provided by sultan mehmood kamran, UNICEF:
Publications:

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Responsible Party: sultan mehmood kamran, Classified Medical specialist, UNICEF
ClinicalTrials.gov Identifier: NCT04491994    
Other Study ID Numbers: Sultan Mehmood Kamran 2
First Posted: July 30, 2020    Key Record Dates
Results First Posted: August 21, 2020
Last Update Posted: August 21, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: data can be shared on demand in SPSS sheet
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: any time when asked
Access Criteria: by email

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by sultan mehmood kamran, UNICEF:
COVID-19
viral clearance
, mild infection
disease progression
trial
HCQ
Additional relevant MeSH terms:
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Disease Progression
Disease Attributes
Pathologic Processes