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0 0.5 1 1.5 2+ Mortality, HCQ vs. non-.. 71% Improvement Relative Risk Mortality, HCQ+X vs. X 71% Improvement by 2 points 4% Viral clearance 10% HCQ  PROTECT  EARLY TREATMENT  RCT Is early treatment with HCQ beneficial for COVID-19? RCT 471 patients in Pakistan Trial compares with azithromycin and oseltamivir Lower mortality with HCQ (p=0.028) Azhar et al., Pakistan J. Medical Scie.., Mar 2024 Favors HCQ Favors azithromycin..

Effectiveness of early pharmaceutical interventions in symptomatic COVID-19 patients: A randomized clinical trial

Azhar et al., Pakistan Journal of Medical Sciences, doi:10.12669/pjms.40.5.8757, PROTECT, NCT04338698
Mar 2024  
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HCQ for COVID-19
1st treatment shown to reduce risk in March 2020
*, now known with p < 0.00000000001 from 422 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.
4,000+ studies for 60+ treatments.
RCT 471 mild COVID-19 patients in Pakistan showing no significant differences in clinical improvement and viral clearance between HCQ, azithromycin, oseltamivir, and combinations. Mortality was significantly lower in HCQ vs. non-HCQ arms. The best results for viral clearance and clinical improvement were seen with the combination of all treatments. There was no control group. No serious adverse events were reported. All patients had mild COVID-19 and the paper indicates early treatment, however time from onset is not reported and minimal baseline information is provided.
risk of death, 71.3% lower, RR 0.29, p = 0.03, treatment 4 of 248 (1.6%), control 10 of 178 (5.6%), NNT 25, HCQ arms vs. non-HCQ arms.
risk of death, 70.8% lower, RR 0.29, p = 0.05, treatment 3 of 183 (1.6%), control 10 of 178 (5.6%), NNT 25, HCQ + OS/AZ/OS+AZ vs. OS/AZ/OS+AZ.
risk of no improvement by 2 points, 4.3% lower, RR 0.96, p = 0.64, treatment 157 of 274 (57.3%), control 118 of 197 (59.9%), NNT 38, HCQ arms vs. non-HCQ arms.
risk of no viral clearance, 10.5% lower, RR 0.90, p = 0.52, treatment 66 of 274 (24.1%), control 53 of 197 (26.9%), NNT 36, HCQ arms vs. non-HCQ arms.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Azhar et al., 18 Mar 2024, Randomized Controlled Trial, Pakistan, peer-reviewed, 22 authors, dosage 200mg tid days 1-5, this trial compares with another treatment - results may be better when compared to placebo, trial NCT04338698 (history) (PROTECT).
This PaperHCQAll
Effectiveness of early pharmaceutical interventions in symptomatic COVID-19 patients: A randomized clinical trial
Shehnoor Azhar, Javed Akram, Waqas Latif, Naomi Cano Ibanez, Samiullah Mumtaz, Ali Rafi, Usman Aftab, Somia Iqtadar, Muhammad Shahzad, Fibhaa Syed, Bilal Zafar, Nighat Fatima, Saleh Saadat Afridi, Shehla Javed Akram, Muhammad Afzal Chaudhary, Farah Sadiq, Saifullah Goraya, Muhammad Hanif, Verda Ashraf, Saadia Ashraf, Humaira Akram, Tanwir Khaliq
Objective: We assessed the effectiveness of oral Hydroxychloroquine (HC), Azithromycin (AZ) and Oseltamivir (OS), alone or combined, among patients hospitalized with mildly symptomatic coronavirus infectious disease (COVID-19). Methods: Following the approval of the National Bioethics Committee and prospective registration ( NCT04338698), a multicenter randomized clinical trial of adaptive design was conducted at 10 multispecialty hospitals in Pakistan. Patients were randomized into seven treatment groups. Starting April 15, 2020, consenting, eligible, otherwise healthy adult patients or those with co-morbidities under control, were recruited if they presented with mildly symptomatic COVID-19 (scored 3 on a 7-point ordinal scale anchored between 1 = not hospitalized, able to undertake normal activities, to 7 = death) confirmed by quantitative Real-Time Polymerase Chain Reaction (qRT-PCR). Two primary outcomes were assessed by day seven: Turning qRT-PCR negative; and clinical improvement of two points from the baseline. Outcome rates were compared using a chi-square test. Multiple imputations were applied to handle missing data. An interim data analysis was carried out on July 19, 2020, following which the study continued without treatment group changes. Data Safety and Monitoring Board advised to stop recruitment due to its futility on January 18, 2021. Results: Of 471 patients randomized, a total of 426 (90.4%) completed the follow-up for primary outcomes. Based on imputed data analyses at day seven: Total qRT-PCR negative cases were 137/471 (29%, 95% CI 25.0 -33.4). By day seven, a total of 111/471 (23.5%, 95% CI 19.8 -27.6) showed clinical improvement. No serious or non-serious adverse event was reported. Conclusions: Among patients with mild COVID-19, there was no statistically significant difference in the effectiveness of oral antimalarial, antiviral, or antibiotic treatments.
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