Clinical trial NCT04328272: Effectiveness of Hydroxychloroquine in Covid-19 Patients
Official title: Effectiveness of Hydroxychloroquine in Covid-19 Patients: A Single Centred Single-blind RCT Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID19
Keywords: covid 19
treatment
Lead sponsor: Ayub Medical College, Abbottabad
Sponsor class: OTHER
Collaborators: name: Ayub Medical College, Abbottabad
First posted: 2020-03-31
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: three parallel groups randomly asserted for intervention
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: National Early Warning Score equal to zero
timeFrame: 3-5 Days
Secondary outcomes:
measure: C-reactive proteins
timeFrame: 3-5 Days
measure: Lymphocyte Count
timeFrame: 3-5days
measure: d-dimers
timeFrame: 3-5days
Other outcomes:
Locations:
city: Abbottābād
country: Pakistan
facility: Ayub Teaching Institution
state: K.p.k
Study officials:
affiliation: Khyber Medical University Peshawer
name: Umar Farooq, PhD
role: PRINCIPAL_INVESTIGATOR
References: