Effectiveness of Hydroxychloroquine in Covid-19 Patients

Prof. Dr. Umar Farooq

Status and phase

Unknown

Phase 3

Conditions

COVID19

Treatments

Drug: Hydroxychloroquine 200 Mg Oral Tablet

Dietary Supplement: Glucose tablets

Drug: Azithromycin 500Mg Oral Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT04328272

Ath/ct101/22/3

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

75 participants in 3 patient groups, including a placebo group

Hydroxychloroquine

Experimental group

Description:

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.

Treatment:

Drug: Hydroxychloroquine 200 Mg Oral Tablet

Azithromycin

Active Comparator group

Description:

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.

Treatment:

Drug: Azithromycin 500Mg Oral Tablet

Drug: Hydroxychloroquine 200 Mg Oral Tablet

Suger Tablets

Placebo Comparator group

Description: