Trial Outcomes & Findings for Clearing the Fog: Is Hydroxychloroquine Effective in Reducing COVID-19 Progression (NCT NCT04491994)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

540 participants

Primary outcome timeframe

5 days

Results posted on

2020-08-21

Participant Flow

Enrollment during 10th April to 31st May 2020 at department of Pulmonology, Pakistan Emirates Military Hospital (PEMH) Pakistan.

672 confirmed PCR positive cases were assessed for eligibility. 132 did not meet selection criteria and excluded.Later,15 withdrew consent and 5 became symptomatic. During follow up 13 patients were found to be deviated from advised therapy and 7 were lost to follow up yielding a final study population of 500.

Participant milestones

Participant milestones
Measure	Control Group Standard of care (SOC) treatment comprised of oral Vit C, oral Zinc, oral Vit-D and tablet Paracetamol (for body aches/fever), intravenous fluids, hemodynamic monitoring, and laboratory testing for SARS-CoV-2 and baseline blood parameters.	Intervention Group Patients selected in experimental arm will be given standard doses of tab HCQ in addition to standard of care (SOC) treatment. side effects will be monitored HCQ: Tab HCQ 400mg 12 hourly day 0 followed by tab HCQ 200mg 12 hrly for next 5 days
Overall Study STARTED	180	360
Overall Study COMPLETED	151	349
Overall Study NOT COMPLETED	29	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Group Standard of care (SOC) treatment comprised of oral Vit C, oral Zinc, oral Vit-D and tablet Paracetamol (for body aches/fever), intravenous fluids, hemodynamic monitoring, and laboratory testing for SARS-CoV-2 and baseline blood parameters.	Intervention Group Patients selected in experimental arm will be given standard doses of tab HCQ in addition to standard of care (SOC) treatment. side effects will be monitored HCQ: Tab HCQ 400mg 12 hourly day 0 followed by tab HCQ 200mg 12 hrly for next 5 days
Overall Study Withdrawal by Subject	10	5
Overall Study developed fever > 3 days	4	1
Overall Study Protocol Violation	11	2
Overall Study Lost to Follow-up	4	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supportive Arm n=180 Participants Patients selected in supportive arm will be given standard doses of oral Vit C, Vit D, Zinc and panadol	HCQ Arm n=360 Participants Patients selected in experimental arm will be given standard doses of tab HCQ in addition to supportive treatment. side effects will be monitored HCQ: Tab HCQ 400mg 12 hourly day 0 followed by tab HCQ 200mg 12 hrly for next 5 days	Total n=540 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=180 Participants	0 Participants n=360 Participants	0 Participants n=540 Participants
Age, Categorical Between 18 and 65 years	180 Participants n=180 Participants	360 Participants n=360 Participants	540 Participants n=540 Participants
Age, Categorical >=65 years	0 Participants n=180 Participants	0 Participants n=360 Participants	0 Participants n=540 Participants
Sex: Female, Male Female	10 Participants n=180 Participants	24 Participants n=360 Participants	34 Participants n=540 Participants
Sex: Female, Male Male	170 Participants n=180 Participants	336 Participants n=360 Participants	506 Participants n=540 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Pakistan	180 participants n=180 Participants	360 participants n=360 Participants	540 participants n=540 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Standard of Care (SOC) n=151 Participants Standard of care (SOC) treatment comprised of daily oral Vit C (2gms), oral Zinc (50mg), oral Vit-D (alfacalcidol 1ug) and tablet Paracetamol (for body aches/fever), intravenous fluids, hemodynamic monitoring, and laboratory testing for SARS-CoV-2 and baseline blood parameters	Intervention Group n=349 Participants Patients selected in intervention arm were given HCQ in addition to standard of care treatment. After 12 hours of randomization HCQ was given. Standard dose of HCQ was 400 mg by mouth twice a day for day one followed by 200 mg 12 hourly for next 5 days.
Number of Participants With Progression	5 Participants	11 Participants

SECONDARY outcome

Timeframe: 14 days

PCR negativity on day 7 and 14 after admission

Outcome measures

Outcome data not reported

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sultan Mehmood Kamran

Pak Emirates Military Hospital (PEMH) Rawalpindi

Phone: +923008501100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place