Evidence map›Paper›PMID 38827854›Full record

ArticlePakistan journal of medical sciences

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 and 12 more

Registry-linked trialAbstract read
In one paragraph

Article in Pakistan journal of medical sciences. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04338698 (Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04338698 phase3completednot on this map

Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment

TypeinterventionalSponsorShehnoor AzharRan2020 to 2020Enrolled550ConditionsCOVID 19ArmsHydroxychloroquine, Oseltamivir, Azithromycin
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Shehnoor AzharShehnoor Azhar (BDS, MPH) Doctoral candidate in Epidemiology and Public Health, University of Granada.
Javed AkramJaved Akram, (MBBS, FRCP) Professor of Medicine and former Vice Chancellor, University of Health Sciences (UHS) Lahore.
Waqas LatifWaqas Latif, (M.Phil Statistics) Data Analyst, University of Health Sciences (UHS) Lahore.
Naomi Cano IbanezNaomi Cano Ibanez, (PhD) Department of Preventive Medicine and Public Health, University of Granada.
Samiullah MumtazSamiullah Mumtaz, (MBBS, FCPS) Assistant Professor at Department of Medicine, King Edward Medical University (KEMU) Lahore.
Ali RafiAli Rafi, (MBBS, MPhil) Faculty member at Department of Pharmacology, University of Health Sciences (UHS) Lahore.
Usman AftabUsman Aftab, (PhD) Assistant Professor at Department of Pharmacology, University of Health Sciences (UHS) Lahore.
Somia IqtadarSomia Iqtadar, (MBBS, FRCP) Associate Professor at Department of Medicine, King Edward Medical University (KEMU) Lahore.
Muhammad ShahzadMuhammad Shahzad, (PhD) Professor and Head of Department of Pharmacology, University of Health Sciences (UHS) Lahore.
Fibhaa SyedFibhaa Syed, (MBBS, FCPS) Assistant Professor at Department of Medicine, Shaheed Zulfiqar Ali Bhutto Medical, University (SZABMU) Islamabad.
Bilal ZafarBilal Zafar, (MBBS) Registrar at Department of Medicine in HFH Rawalpindi, Rawalpindi Medical University (RMU) and affiliated hospitals.
Nighat FatimaNighat Fatima, (MBBS) Medical Officer at Department of Medicine, Sargodha Medical College and its affiliated District Headquarter Hospital (DHQ) Sargodha.
Saleh Saadat AfridiSaleh Saadat Afridi, (MBBS, FCPS) Senior Registrar at Department of Medicine, Naseer Teaching Hospital (NTH) Peshawar.
Shehla Javed AkramShehla Javed Akram, (MBBS, DTM&H, DCH, PhD candidate) Chief Executive Officer, Akram Medical Complex (AMC) Lahore.
Muhammad Afzal ChaudharyMuhammad Afzal Chaudhary, (MBBS, FCPS) Associate Professor at Department of Medicine, Aziz Bhatti Shaheed Teaching Hospital (ABSTH) Gujrat.
Farah SadiqFarah Sadiq , (MBBS, FCPS) Associate Professor of Medicine, Lahore General Hospital (LGH) Lahore.
Saifullah GorayaSaifullah Goraya, (MBBS, FCPS) Professor of Medicine, Sargodha Medical College and its affiliated District Headquarter Hospital (DHQ) Sargodha.
Muhammad HanifMuhammad Hanif, (MBBS, FCPS) Professor of Medicine, Faisalabad Medical University (FMU) Faisalabad.
Verda AshrafVerda Ashraf, (MBBS) Registrar at Department of Radiology, Akram Medical Complex (AMC) Lahore.
Saadia AshrafSaadia Ashraf, (MBBS, FCPS) Professor of Pulmonology, Khyber Teaching Hospital (KTH) Peshawar.
Humaira AkramHumaira Akram, (MBBS, FCPS) Professor of Gynecology, Sargodha Medical College and its affiliated District Headquarter Hospital (DHQ) Sargodha.
Tanwir KhaliqTanwir Khaliq, (MBBS, FRCS) Professor of Surgery and Vice Chancellor SZABMU Islamabad, Shaheed Zulfiqar Ali Bhutto Medical, University (SZABMU) Islamabad.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

COVID-19EffectivenessFollow-upHospitalizationPatientsSARS-CoV-2

Identifiers

PMID38827854
PMCPMC11140354

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.