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

Autor: Azhar S; Shehnoor Azhar (BDS, MPH) Doctoral candidate in Epidemiology and Public Health, University of Granada., Akram J; Javed Akram, (MBBS, FRCP) Professor of Medicine and former Vice Chancellor, University of Health Sciences (UHS) Lahore., Latif W; Waqas Latif, (M.Phil Statistics) Data Analyst, University of Health Sciences (UHS) Lahore., Ibanez NC; Naomi Cano Ibanez, (PhD) Department of Preventive Medicine and Public Health, University of Granada., Mumtaz S; Samiullah Mumtaz, (MBBS, FCPS) Assistant Professor at Department of Medicine, King Edward Medical University (KEMU) Lahore., Rafi A; Ali Rafi, (MBBS, MPhil) Faculty member at Department of Pharmacology, University of Health Sciences (UHS) Lahore., Aftab U; Usman Aftab, (PhD) Assistant Professor at Department of Pharmacology, University of Health Sciences (UHS) Lahore., Iqtadar S; Somia Iqtadar, (MBBS, FRCP) Associate Professor at Department of Medicine, King Edward Medical University (KEMU) Lahore., Shahzad M; Muhammad Shahzad, (PhD) Professor and Head of Department of Pharmacology, University of Health Sciences (UHS) Lahore., Syed F; Fibhaa Syed, (MBBS, FCPS) Assistant Professor at Department of Medicine, Shaheed Zulfiqar Ali Bhutto Medical, University (SZABMU) Islamabad., Zafar B; Bilal Zafar, (MBBS) Registrar at Department of Medicine in HFH Rawalpindi, Rawalpindi Medical University (RMU) and affiliated hospitals., Fatima N; Nighat Fatima, (MBBS) Medical Officer at Department of Medicine, Sargodha Medical College and its affiliated District Headquarter Hospital (DHQ) Sargodha., Afridi SS; Saleh Saadat Afridi, (MBBS, FCPS) Senior Registrar at Department of Medicine, Naseer Teaching Hospital (NTH) Peshawar., Akram SJ; Shehla Javed Akram, (MBBS, DTM&H, DCH, PhD candidate) Chief Executive Officer, Akram Medical Complex (AMC) Lahore., Chaudhary MA; Muhammad Afzal Chaudhary, (MBBS, FCPS) Associate Professor at Department of Medicine, Aziz Bhatti Shaheed Teaching Hospital (ABSTH) Gujrat., Sadiq F; Farah Sadiq , (MBBS, FCPS) Associate Professor of Medicine, Lahore General Hospital (LGH) Lahore., Goraya S; Saifullah Goraya, (MBBS, FCPS) Professor of Medicine, Sargodha Medical College and its affiliated District Headquarter Hospital (DHQ) Sargodha., Hanif M; Muhammad Hanif, (MBBS, FCPS) Professor of Medicine, Faisalabad Medical University (FMU) Faisalabad., Ashraf V; Verda Ashraf, (MBBS) Registrar at Department of Radiology, Akram Medical Complex (AMC) Lahore., Ashraf S; Saadia Ashraf, (MBBS, FCPS) Professor of Pulmonology, Khyber Teaching Hospital (KTH) Peshawar., Akram H; Humaira Akram, (MBBS, FCPS) Professor of Gynecology, Sargodha Medical College and its affiliated District Headquarter Hospital (DHQ) Sargodha., Khaliq T; Tanwir Khaliq, (MBBS, FRCS) Professor of Surgery and Vice Chancellor SZABMU Islamabad, Shaheed Zulfiqar Ali Bhutto Medical, University (SZABMU) Islamabad.
Jazyk: angličtina
Zdroj: Pakistan journal of medical sciences [Pak J Med Sci] 2024 May-Jun; Vol. 40 (5), pp. 800-810.
DOI: 10.12669/pjms.40.5.8757
Abstrakt: 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 (clinicaltrials.gov 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. Clinicaltrials.gov ID: NCT04338698.
(Copyright: © Pakistan Journal of Medical Sciences.)
Databáze: MEDLINE
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