Clearing the Fog: Is Hydroxychloroquine Effective in Reducing COVID-19 Progression (COVID-19)
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| ClinicalTrials.gov Identifier: NCT04491994 |
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Recruitment Status :
Completed
First Posted : July 30, 2020
Results First Posted : August 21, 2020
Last Update Posted : August 21, 2020
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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 |
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.
| 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 |
|---|---|
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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).
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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
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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) |
- 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
- Viral Clearance [ Time Frame: 14 days ]PCR negativity on day 7 and 14 after admission
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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 |
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
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
| Pakistan | |
| Pak Emirates Military Hospital | |
| Rawalpindi, Punjab, Pakistan, 46000 | |
| Study Director: | Imran m Fazal, FCPS | Pak Emirates Military Hospital (PEMH) Rawalpindi |
Documents provided by sultan mehmood kamran, UNICEF:
| 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 |
| 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 |
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COVID-19 viral clearance , mild infection |
disease progression trial HCQ |
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Disease Progression Disease Attributes Pathologic Processes |