Official Title
Effectiveness of Hydroxychloroquine in Covid-19 Patients: A Single Centred Single-blind RCT Study
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.

Unknown status
COVID19

Drug: Hydroxychloroquine 200 Mg Oral Tablet

Hydroxychloroquine administered orally with water
Other Name: Plaquenil

Drug: Azithromycin 500Mg Oral Tablet

Azithromycin administered orally with water
Other Name: Zetro

Dietary Supplement: Glucose tablets

administered orally with water
Other Name: Canderel

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 50 Years
Countries
Pakistan
Locations

Ayub Teaching Institution
Abbottābād, K.p.k, Pakistan

Investigator: Umer Farooq, PhD
Contact: 00929929311100
dean@ayubmed.edu.pk

Contacts

Umar Farooq, PhD
00923219111681
dean@ayubmed.edu.pk

Muhammad J Khan, MBBS
00923444566444
junaidkhan@ayubmed.edu.pk

Umar Farooq, PhD, Principal Investigator
Khyber Medical University Peshawer

Ayub Medical College, Abbottabad
NCT Number
Keywords
COVID 19
treatment
MeSH Terms
COVID-19
Azithromycin
Hydroxychloroquine