Effectiveness of Hydroxychloroquine in Covid-19 Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-28

Study Completion Date

2020-06-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COVID19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

three parallel groups randomly asserted for intervention

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Single blinded:

As, the disease is novel and putting the lives at risk is unethical. therefore, It is important for investigator to know the group and carry close regular monitoring of participants so that proper further intervention can be made when required.

Study Groups

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Hydroxychloroquine

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.

Group Type EXPERIMENTAL

Hydroxychloroquine 200 Mg Oral Tablet

Intervention Type DRUG

Hydroxychloroquine administered orally with water

Azithromycin

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.

Group Type ACTIVE_COMPARATOR

Hydroxychloroquine 200 Mg Oral Tablet

Intervention Type DRUG

Hydroxychloroquine administered orally with water

Azithromycin 500Mg Oral Tablet

Intervention Type DRUG

Azithromycin administered orally with water

Suger Tablets

Placebo (sugar tablet) twice daily for 7 days

Group Type PLACEBO_COMPARATOR

Glucose tablets

Intervention Type DIETARY_SUPPLEMENT

administered orally with water

Interventions

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Hydroxychloroquine 200 Mg Oral Tablet

Hydroxychloroquine administered orally with water

Intervention Type DRUG

Azithromycin 500Mg Oral Tablet

Azithromycin administered orally with water

Intervention Type DRUG

Glucose tablets

administered orally with water

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Plaquenil Zetro Canderel

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No