Prof. Dr. Umar Farooq
Prof. Dr. Umar Farooq
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.
COVID19
Hydroxychloroquine 200 Mg Oral Tablet
Azithromycin 500Mg Oral Tablet
Glucose tablets
Phase 3
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 Type : | Interventional |
| Estimated Enrollment : | 75 participants |
| Masking : | Single |
| Masking Description : | 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. |
| Primary Purpose : | Treatment |
| Official Title : | Effectiveness of Hydroxychloroquine in Covid-19 Patients: A Single Centred Single-blind RCT Study |
| Actual Study Start Date : | March 28, 2020 |
| Estimated Primary Completion Date : | May 28, 2020 |
| Estimated Study Completion Date : | June 28, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 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. |
Drug: Hydroxychloroquine 200 Mg Oral Tablet |
|
Active Comparator: 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. |
Drug: Hydroxychloroquine 200 Mg Oral Tablet |
|
Placebo Comparator: Sugar Tablets Placebo (sugar tablet) twice daily for 7 days |
Drug: Azithromycin 500Mg Oral Tablet |
| Ages Eligible for Study: | 18 Years to 50 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Ayub Teaching Institution
Abbottabad, K.p.k, Pakistan, 00532