COVID 19
Conditions
Brief summary
To evaluate the effectiveness of Hydroxychloroquine Sulfate (200 mg orally 8hr thrice a day for 5 days) vs oseltamivir (75 mg orally twice a day for 5 days) vs Azithromycin (500 mg orally daily on day 1, followed by 250 mg orally twice a day on days 2-5) alone and in combination (in all seven groups), in clearing the coronavirus nucleic acid from throat and nasal swab and in bringing about clinical improvement on day 7 of follow-up (primary outcomes).
Detailed description
A scientific taskforce notified by the Ministry of Science and Technology of the Government of Pakistan will oversee a comprehensive cohort study. Within this cohort, a multicenter, adaptive, randomized controlled trial will evaluate, among eligible SARS-Cov-2 (COVID-19) infected patients receiving standard supportive care who consent to randomization following a new diagnosis in Pakistan, if Hydroxychloroquine Sulfate alone (control intervention) vs a series of alternatives (comparator interventions) including Oseltamivir and Azithromycin alone and in combination with Hydroxychloroquine Sulfate is effective in clearing the coronavirus and improving the clinical course of the disease. Those not consenting to randomization will be followed up for outcomes of SARS-Cov-2 infection with supportive care only. Findings of this study are expected to inform clinical care and public health protocols and policies for management of SARS-Cov-2.
Interventions
DRUGHydroxychloroquine
Hydroxychloroquine Sulfate (200 mg orally thrice a day for 5 days)
DRUGOseltamivir
Oseltamivir (75 mg orally twice a day for 5 days)
DRUGAzithromycin
Azithromycin (500 mg orally once a day on day 1, followed by 250 mg orally daily on days 2-5)
Sponsors
Shehnoor Azhar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Adaptive design (sample size given below is indicative)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Confirmed SARS-CoV-2 (COVID-19) infection by a positive test result 2. Either gender 3. Symptomatic for example fever, dry Cough, difficulty to breathe
Exclusion criteria
1. Confirmed absence of SARS-CoV-2 (COVID-19) infection by a negative test result 2. Have chronic conditions such as heart disease, liver and kidney failure 3. Pregnant or currently lactating 4. Immunocompromise and/or systemic disease(s) 5. On other antiviral drugs 6. History of allergy to any of the drugs to be administered in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Laboratory Result | Day 07 on follow-up | The laboratory-based primary outcome will be turning test negative for COVID-19 on RT-qPCR calculated as viral load of \< 150 i.u |
| Clinical Outcome | Day 07 on follow-up | The clinical primary outcome will be improvement of two points on a seven-category ordinal scale shown below: 1. Not hospitalized, able to resume normal activities 2. Not hospitalized, but unable to resume normal activities 3. Hospitalization, not requiring supplemental oxygen 4. Hospitalization, requiring supplemental oxygen 5. Hospitalization, requiring noninvasive mechanical ventilation 6. Hospitalization, requiring invasive mechanical ventilation 7. Death |
Countries
Pakistan
Outcome results
None listed