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All Studies   Meta Analysis    Recent:   

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

Akram et al., Trials, doi:10.1186/s13063-020-04616-4, PROTECT, NCT04338698
Nov 2020  
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HCQ for COVID-19
1st treatment shown to reduce risk in March 2020
 
*, now known with p < 0.00000000001 from 421 studies, recognized in 42 countries.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
3,800+ studies for 60+ treatments. c19hcq.org
550 patient HCQ early treatment RCT with results not reported over 3 years after completion.
39 HCQ RCTs have results missing long after expected Abayomi, Abu-Helalah, Ajili, Akram, Al Ansari, Aston, Borrie, Burney, Butler, Chauffe, Connor, El-Sherbiny, Farooq, Gagneux-Brunon, Genton, Ghanem-Zoubi, González, Granados-Montiel, Gül, Hawari, James, Kara, Kim, Levi, Mežnar, Moraes, Morales-Asencio, Mordmüller, Nanni, Niriella, Okasha, Pellegrini, Pineda, Sarwar, Sarwar (B), Sow, Treluyer, WellStar, White
The trials report a total of 25,949 patients, with 13 trials having actual enrollment of 8,689, and the remainder estimated.
Akram et al., 22 Nov 2020, Randomized Controlled Trial, Pakistan, peer-reviewed, trial NCT04338698 (history) (PROTECT). Contact: shehnoor.azhar@gmail.com (corresponding author).
This PaperHCQAll
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
Javed Akram, Shehnoor Azhar, Muhammad Shahzad, Waqas Latif, Khalid Saeed Khan
Trials, doi:10.1186/s13063-020-04616-4
Objectives: To evaluate the effectiveness of Hydroxychloroquine Phosphate/Sulfate (200 mg orally 8 hourly thrice a day for 5 days), versus oseltamivir (75 mg orally twice a day for 5 days), and versus 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 (COVID-19) nucleic acid from throat and nasal swab and in bringing about clinical improvement on day 7 of follow-up (primary outcomes). Trial Design: An adaptive design, set within a comprehensive cohort study, to permit flexibility in this fastchanging clinical and public health scenario. The randomized study will be a multicenter, multiarm, multistage, randomized controlled trial with a parallel design. An observation only cohort will emerge from those not consenting to randomization.
Supplementary information Supplementary information accompanies this paper at https://doi.org/10. 1186/s13063-020-04616-4. Ethics approval The proposed study is approved by the National Bioethics Committee of Pakistan on April 22, 2020 (reference No.4-87/NBC-471-COVID-19-05/20/) and IRBs at most of the participating sites. Remaining sites have endorsed the ethics approval of both University of Health Sciences Lahore and National Bioethics Committee (NBC). Participants' informed consent is intended to be sought on printed proforma designed in local language and no individual under the age of 18 years is to be enrolled. Certified that this trial has received ethical approval from the appropriate ethical committee as described above Consent for publication Not Applicable Competing interests The authors declare that they have no competing interests
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