Publications and retracted articles of COVID-19 pharmacotherapy-related research: A systematic review

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Abstract

The current COVID-19 pandemic situation has stimulated an unplanned clinical research paradigm which is evident from the surge of clinical trial registrations and the increasing number of COVID-related publications. We aimed to explore the standards for research conduction, publications and retraction of articles related to COVID-19 pharmacotherapy research during the pandemic. We analysed data from the contemporary literatures on studies reporting pharmacological agents for COVID-19 using MEDLINE, PubMed, WHO database and Google Scholar between January 01, 2020 and March 20, 2021. The initial search revealed a total of 61,801 articles. Based on the inclusion criteria, a total of 124 studies related to various pharmacological agents were included in the final analysis. Most of the studies were reported from the United States ( n = 30, 24%). Of the 124 studies, 50 (40%) were randomized controlled trials (RCTs). Immunomodulatory drugs-related ( n = 17, 34%) and COVID-19 vaccine-related studies ( n = 14, 28%) were the main topics in the relevant RCTs. The median days for dissemination of findings in journals were 114 days (IQR 61–189). A comparative analysis revealed that RCTs were disseminated earlier (median 79 days; IQR 52–131) when compared to observational studies (median = 144 days; IQR 69–206) ( p = 0.003). Six papers were retracted from high impact journals; in which the average period till publication was 33 days. Retraction of papers occurred within 10–48 days. Expedited reviews, research approval and early publications of COVID-19 related pharmaceutical studies could have an impact on the quality of publications. However, the huge number of publications in short time creates confusion for readers during the early phases of the pandemic. Retraction of papers is alarming but ensures research integrity and correctness of scientific information. These abbreviated processes could affect patient care and public awareness. It is imperative to follow rapid but rigours ethical standards for research approval and peer-review process for publications during health pandemics.

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Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report

Mark Peters (2020)

Abstract Background Coronavirus disease 2019 (Covid-19) is associated with diffuse lung damage. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death. Methods In this controlled, open-label trial comparing a range of possible treatments in patients who were hospitalized with Covid-19, we randomly assigned patients to receive oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days or to receive usual care alone. The primary outcome was 28-day mortality. Here, we report the preliminary results of this comparison. Results A total of 2104 patients were assigned to receive dexamethasone and 4321 to receive usual care. Overall, 482 patients (22.9%) in the dexamethasone group and 1110 patients (25.7%) in the usual care group died within 28 days after randomization (age-adjusted rate ratio, 0.83; 95% confidence interval [CI], 0.75 to 0.93; P<0.001). The proportional and absolute between-group differences in mortality varied considerably according to the level of respiratory support that the patients were receiving at the time of randomization. In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94) but not among those who were receiving no respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.91 to 1.55). Conclusions In patients hospitalized with Covid-19, the use of dexamethasone resulted in lower 28-day mortality among those who were receiving either invasive mechanical ventilation or oxygen alone at randomization but not among those receiving no respiratory support. (Funded by the Medical Research Council and National Institute for Health Research and others; RECOVERY ClinicalTrials.gov number, NCT04381936; ISRCTN number, 50189673.)

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Remdesivir for the Treatment of Covid-19 — Final Report

John H. Beigel, Kay Tomashek, Lori Dodd … (2022)

Abstract Background Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), none have yet been shown to be efficacious. Methods We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only. Results A total of 1063 patients underwent randomization. The data and safety monitoring board recommended early unblinding of the results on the basis of findings from an analysis that showed shortened time to recovery in the remdesivir group. Preliminary results from the 1059 patients (538 assigned to remdesivir and 521 to placebo) with data available after randomization indicated that those who received remdesivir had a median recovery time of 11 days (95% confidence interval [CI], 9 to 12), as compared with 15 days (95% CI, 13 to 19) in those who received placebo (rate ratio for recovery, 1.32; 95% CI, 1.12 to 1.55; P<0.001). The Kaplan-Meier estimates of mortality by 14 days were 7.1% with remdesivir and 11.9% with placebo (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04). Serious adverse events were reported for 114 of the 541 patients in the remdesivir group who underwent randomization (21.1%) and 141 of the 522 patients in the placebo group who underwent randomization (27.0%). Conclusions Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705.)

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A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19

Bin Cao, Yeming Wang, Danning Wen … (2020)

Abstract Background No therapeutics have yet been proven effective for the treatment of severe illness caused by SARS-CoV-2. Methods We conducted a randomized, controlled, open-label trial involving hospitalized adult patients with confirmed SARS-CoV-2 infection, which causes the respiratory illness Covid-19, and an oxygen saturation (Sao 2) of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen (Pao 2) to the fraction of inspired oxygen (Fio 2) of less than 300 mm Hg. Patients were randomly assigned in a 1:1 ratio to receive either lopinavir–ritonavir (400 mg and 100 mg, respectively) twice a day for 14 days, in addition to standard care, or standard care alone. The primary end point was the time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first. Results A total of 199 patients with laboratory-confirmed SARS-CoV-2 infection underwent randomization; 99 were assigned to the lopinavir–ritonavir group, and 100 to the standard-care group. Treatment with lopinavir–ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.24; 95% confidence interval [CI], 0.90 to 1.72). Mortality at 28 days was similar in the lopinavir–ritonavir group and the standard-care group (19.2% vs. 25.0%; difference, −5.8 percentage points; 95% CI, −17.3 to 5.7). The percentages of patients with detectable viral RNA at various time points were similar. In a modified intention-to-treat analysis, lopinavir–ritonavir led to a median time to clinical improvement that was shorter by 1 day than that observed with standard care (hazard ratio, 1.39; 95% CI, 1.00 to 1.91). Gastrointestinal adverse events were more common in the lopinavir–ritonavir group, but serious adverse events were more common in the standard-care group. Lopinavir–ritonavir treatment was stopped early in 13 patients (13.8%) because of adverse events. Conclusions In hospitalized adult patients with severe Covid-19, no benefit was observed with lopinavir–ritonavir treatment beyond standard care. Future trials in patients with severe illness may help to confirm or exclude the possibility of a treatment benefit. (Funded by Major Projects of National Science and Technology on New Drug Creation and Development and others; Chinese Clinical Trial Register number, ChiCTR2000029308.)

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Journal

Journal ID (nlm-ta): Sci Prog

Journal ID (iso-abbrev): Sci Prog

Journal ID (publisher-id): SCI

Journal ID (hwp): spsci

Title: Science Progress

Publisher: SAGE Publications (Sage UK: London, England )

ISSN (Print): 0036-8504

ISSN (Electronic): 2047-7163

Publication date (Electronic): 14 May 2021

Publication date Collection: Apr-Jun 2021

Volume: 104

Issue: 2

Electronic Location Identifier: 00368504211016936

Affiliations

[1 ]Clinical Medicine, Weill Cornell Medical College, Doha, Qatar

[2 ]Clinical Research, Trauma Surgery, Hamad General Hospital, Doha, Qatar

[3 ]Injury Prevention Program, Trauma Surgery, Hamad General Hospital, Doha, Qatar

[4 ]Trauma Surgery, Hamad General Hospital, Doha, Qatar

Author notes

[*]Ayman El-Menyar, MD, FRCP, Weill Cornell Medical College & Clinical Research, Trauma and Vascular Surgery, Hamad General Hospital, PO Box 3050, Doha, Qatar. Email: aymanco65@ 123456yahoo.com

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Ayman El-Menyar https://orcid.org/0000-0003-2584-953X

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Publisher ID: 10.1177_00368504211016936

DOI: 10.1177/00368504211016936

PMC ID: 10454799

PubMed ID: 33989091

SO-VID: 53122273-d39f-441a-b410-d0fc92990abb

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This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

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cover-date April-June 2021

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Keywords: covid-19 pandemic,publications,research ethics,retraction,pharmaceutical studies

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Keywords: covid-19 pandemic, publications, research ethics, retraction, pharmaceutical studies

Publications and retracted articles of COVID-19 pharmacotherapy-related research: A systematic review

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Novel Coronavirus Disease COVID-19

Most cited references 78

Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report

Remdesivir for the Treatment of Covid-19 — Final Report

A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19

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