Effectiveness of Hydroxychloroquine in Covid-19 Patients

Phase 3

• Conditions: COVID19
• Interventions: Drug: Hydroxychloroquine 200 Mg Oral Tablet; Dietary Supplement: Glucose tablets; Drug: Azithromycin 500Mg Oral Tablet

• Registration Number: NCT04328272
• Lead Sponsor: Prof. Dr. Umar Farooq

Brief Summary

To find the effectiveness of hydroxychloroquine alone and adjuvant with azithromycin in mild to severe Covide-19 pneumonia patients admitted to Coronavirus cell/ward of Ayub Teaching hospital, Abbottabad Pakistan. A single centered, single-blind randomized control trial study.

Detailed Description

Coronavirus (SARS-nCoV-2) is a member family coronaviridae, order Nidovirales. It is single-stranded, positive sense enveloped RNA discovered in early 1960s. Coronavirus pandemic put a lot of lives at stake. By 19 March 2020, a total of 219238 confirmed cases with 8967 being dead and 85742 recovered cases have been reported. Worldwide, in 9 days, the confirmed death cases have been doubled. The average death rate of Covid-19 per day is approximately 88 patients as of the given date. Unlike, SARS-CoV and MERS-CoV, the disease progression and mortality rate of Covid-19 is startling. The pre-pathogenic course of novel Covid-19 is yet to be determined, so the risk factors, clinical picture and medical intervention too. Only supportive therapy is being practised. Yet many trials of antimalarial drug, chloroquine and quinolone is currently taking place worldwide. According to Cortegiani A, 23 ongoing trials from China have been registered. Clinical experience from recent Wuhan epidemic came up with promising results of chloroquine and hydroxychloroquine in Covid-19 positive patients. Some in-vitro studies suggest that these immunomodulant drugs can interfere with SARS-nCov-2 replication. These are federal drug authority approved medicine for malaria. Yet their effectiveness and safety in treating Covid-19 pneumonia is a question mark.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-03-27
• Study Start: 2020-03-28
• Study First Posted: 2020-03-31
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-02
• Primary Completion: 2020-05-28
• Study Completion: 2020-06-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Confirmed cases of Covid-19 (all by RT-PCR from same laboratory)
• Mild to severe clinical presentation (identified at the time of admission to ward by National Early Warning Score NEWS-2; mild 0-4; severe 5-6)

Exclusion Criteria

• Covid-19 critically ill patients (NEWS-2 score <7),
• Unable to take oral medication,
• Immunocompromised,
• Creatinine clearance (CCL) < 30 ml/min,
• Aspartate transaminase (AST) or alanine transaminase (ALT) > 5 times Upper limit of normal (ULN),
• d-dimer > 2microgram per liter, or
• Known comorbid condition like hypertension, cardiovascular disease, diabetes mellites, asthma, COPD, cerebrovascular disorder, malignancy of any type, pregnancy,
• BMI less than 18
• Smoking history (one pack per day) for past six months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydroxychloroquine	Hydroxychloroquine 200 Mg Oral Tablet	tablet hydroxychloroquine (HCQ). Day-1 (initial) 1st dose, 3 tablets (200 mg per tablet), 2nd dose after 6 hours, 3 tablets (200 mg per tablet) per oral. From day 2 to 7 (maintenance dose), 2 tablets twice a day.
Azithromycin	Azithromycin 500Mg Oral Tablet	Tablet azithromycin (AZC) 500 mg orally as a single dose on day 1, followed by 250 mg orally once a day on days 2 to 7.
Suger Tablets	Glucose tablets	Placebo (sugar tablet) twice daily for 7 days
Azithromycin	Hydroxychloroquine 200 Mg Oral Tablet	Tablet azithromycin (AZC) 500 mg orally as a single dose on day 1, followed by 250 mg orally once a day on days 2 to 7.

Primary Outcome Measures

Name	Time	Method
National Early Warning Score equal to zero	3-5 Days	National Early Warning Score equal to zero is when patients recovered clinically. Respiration 14-20breaths/minute, oxygen saturation percent greater than 96, (without breathing aid), systolic blood pressure 111-180 mmhg, pulse 60-90 beats.minute, alert consciousness and 35.1-38 degree Celsius body temperature.

Secondary Outcome Measures

Name	Time	Method
C-reactive proteins	3-5 Days	below 3.0 miligram/Liter of blood sample
d-dimers	3-5days	less than 250 ng/mL, or less than 0.4 mcg/mL of blood sample
Lymphocyte Count	3-5days	1000 -4800 lymphocytes in 1 microliter of blood

Trial Locations

Locations (1)

Ayub Teaching Institution; 🇵🇰 Abbottābād, K.p.k, Pakistan