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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Intervention | Active Comparator | Hydroxychloroquine |
|
| Comparator 1 | Experimental | Azithromycin |
|
| Comparator 2 | Experimental | Oseltamivir |
|
| Comparator 3 | Experimental | Hydroxychloroquine + Azithromycin |
|
| Comparator 4 | Experimental | Hydroxychloroquine + Oseltamivir |
|
| Comparator 5 | Experimental | Oseltamivir + Azithromycin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | Hydroxychloroquine Sulfate (200 mg orally thrice a day for 5 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory Result | The laboratory-based primary outcome will be turning test negative for COVID-19 on RT-qPCR calculated as viral load of < 150 i.u | Day 07 on follow-up |
| Clinical Outcome | The clinical primary outcome will be improvement of two points on a seven-category ordinal scale shown below:
| Day 07 on follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javed Akram, FRCP | University of Health Sciences Lahore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nawaz Sharif Medical College | Dhok Gujra | Pakistan | ||||
| Faislabad Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38827854 | Derived | Azhar S, Akram J, Latif W, Ibanez NC, Mumtaz S, Rafi A, Aftab U, Iqtadar S, Shahzad M, Syed F, Zafar B, Fatima N, Afridi SS, Akram SJ, Chaudhary MA, Sadiq F, Goraya S, Hanif M, Ashraf V, Ashraf S, Akram H, Khaliq T. Effectiveness of early pharmaceutical interventions in symptomatic COVID-19 patients: A randomized clinical trial. Pak J Med Sci. 2024 May-Jun;40(5):800-810. doi: 10.12669/pjms.40.5.8757. | |
| 35799756 |
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On completion of study, investigators are open to participation in planned IPD projects with a prospective registration, subject to appropriate approvals
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| D053139 | Oseltamivir |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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Adaptive design (sample size given below is indicative)
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| Comparator 6 | Experimental | Hydroxyquinine + Oseltamivir + Azithromycin |
|
| Observational Cohort | No Intervention | Non-consenting to randomization |
| Oseltamivir | Drug | Oseltamivir (75 mg orally twice a day for 5 days) |
|
| Azithromycin | Drug | Azithromycin (500 mg orally once a day on day 1, followed by 250 mg orally daily on days 2-5) |
|
| Faisalābad |
| Pakistan |
| Gujranwala Medical College | Guiranwala | Pakistan |
| Szabmu-Pims | Islamabad | Pakistan |
| Akram Medical Complex | Lahore | Pakistan |
| Fatima Jinnah Medical University | Lahore | Pakistan |
| King Edward Medical University-Mayo Hospital | Lahore | Pakistan |
| Lahore General Hospital | Lahore | Pakistan |
| Khyber Teaching Hospital | Peshawar | Pakistan |
| Rawalpindi Medical University | Rawalpindi | Pakistan |
| Sargodha Medical College | Sargodha | Pakistan |
| Derived |
| Azhar S, Akram J, Shahzad M, Latif W, Khan KS. Protocol of Pakistan randomized and observational trial to evaluate coronavirus treatment among newly diagnosed patients with COVID-19: Azithromycin, Oseltamivir, and Hydroxychloquine. Pak J Med Sci. 2022 May-Jun;38(5):1401-1408. doi: 10.12669/pjms.38.5.5512. |
| 32771032 | Derived | Akram J, Azhar S, Shahzad M, Latif W, Khan KS. Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment (PROTECT) of Hydroxychloroquine, Oseltamivir and Azithromycin to treat newly diagnosed patients with COVID-19 infection who have no comorbidities like diabetes mellitus: A structured summary of a study protocol for a randomized controlled trial. Trials. 2020 Aug 8;21(1):702. doi: 10.1186/s13063-020-04616-4. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |