Evidence map›Paper›PMID 34273635›Full record

ReviewInternational immunopharmacology2021

Umifenovir in hospitalized moderate to severe COVID-19 patients: A randomized clinical trial.

Ilad Alavi Darazam, Shervin Shokouhi, Masoud Mardani, Mohamad Amin Pourhoseingholi, Mohammad Mahdi Rabiei, Firouze Hatami, Minoosh Shabani, Omid Moradi, Farid Javandoust Gharehbagh, Seyed Sina Naghibi Irvani and 12 more

Registry-linked trialOpen access · greenAbstract readReview
In one paragraph

Review in International immunopharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04350684 (Efficacy and Safety of Umifenovir as an Adjuvant Therapy Compared to the Control Therapeutic Regiment of Interferon Beta 1a, Lopinavir / Ritonavir and a Single Dose of Hydroxychloroquine in Moderate to Severe COVID-19), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 10% of its field
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.

NCT04350684 phase4unknown statusnot on this map

Efficacy and Safety of Umifenovir as an Adjuvant Therapy Compared to the Control Therapeutic Regiment of Interferon Beta 1a, Lopinavir / Ritonavir and a Single Dose of Hydroxychloroquine in Moderate to Severe COVID-19: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial

TypeinterventionalSponsorShahid Beheshti University of Medical SciencesRan2020 to 2020Enrolled40ConditionsCOVID-19ArmsUmifenovir, Interferon-β 1a, Lopinavir / Ritonavir, Single Dose of Hydroxychloroquine, Standards of Care
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.

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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 at 1 institution in 1 country.

Ilad Alavi DarazamInfectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: ilad.alavi@sbmu.ac.ir.
Shervin ShokouhiInfectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Masoud MardaniInfectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Mohamad Amin PourhoseingholiGastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Mohammad Mahdi RabieiClinical Research Development Unit of Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Firouze HatamiClinical Research Development Unit of Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Minoosh ShabaniInfectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Omid MoradiStudent Research Committee, Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Farid Javandoust GharehbaghClinical Research Development Unit of Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Seyed Sina Naghibi IrvaniClinical Research Development Unit of Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Mahdi AmirdosaraAnesthesiology Research Center Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Mohammadreza HajiesmaeiliAnesthesiology Research Center Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Omidvar RezaeiSkull Base Research Center, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Ali KhoshkarDepartment of Surgery, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Legha LotfollahiDepartment of Nephrology, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Latif GachkarClinical Research Development Unit of Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Hadiseh Shabanpour DehbsnehDepartment of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Negar KhaliliDepartment of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Azam SoleymaniniaDepartment of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Akram Hoseyni KushaDepartment of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Maryam Taleb ShoushtariDepartment of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Parham TorabinavidClinical Research Development Unit of Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Shahid Beheshti University of Medical Sciences · IR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe effectiveness of umifenovir against COVID-19 is controversial; therefore, clinical trials are crucial to evaluate its efficacy.

methodsThe study was conducted as a single-center, randomized, open-label clinical trial. Eligible moderate-severe hospitalized patients with confirmed SARS-Cov-2 infection were randomly segregated into intervention and control groups. The intervention group were treated with lopinavir/ritonavir (400 mg/100 mg bid for 10-14 days) + hydroxychloroquine (400 mg single dose) + interferon-β1a (Subcutaneous injections of 44 µg (12,000 IU) on days 1, 3, 5) + umifenovir (200 mg trice daily for 10 days), and the control group received lopinavir/ritonavir (same dose) + hydroxychloroquine (same dose) + interferon-β1a (same dose).

resultsOf 1180 patients with positive RT-PCRs and positive chest CT scans, 101 patients were finally included in the trial; 50 were assigned to receive IFNβ1a + hydroxychloroquine + lopinavir/ritonavir group and 51 were managed to treat with IFNβ1a + hydroxychloroquine + lopinavir/ritonavir + umifenovir. Since all patients received the intended treatment as scheduled, the analysis just included as the ITT population. Time to clinical improvement (TTCI) did not hold a statistically significant difference between intervention and control groups (median, 9 days for intervention group versus 7 days for the control group; P: 0.22). Besides, Hazard Ratio for TTCI in the Cox regression model was 0.75 (95% CI: 0.45-1.23, P:0.25) which also confirmed that there was no statistically significant difference between the treatment group and the control group. The mortality was not statistically significant between the two groups (38% in controls vs 33.3% treatment group).

conclusionsOur findings shed new lights on the facts that additional umifenovir has not been found to be effective in shortening the duration of SARS-CoV-2 in severe patients and improving the prognosis in non-ICU patients and mortality.

trial registrationThe trial was confirmed by the Ethics in Medical Research Committee of the Shahid Beheshti University of Medical Sciences. signed informed consents were obtained from all the participants or their legally authorized representatives. This trial has been registered as ClinicalTrials.gov, NCT04350684.

Indexed as

COVID-19 Drug TreatmentAdultAgedAntiviral AgentsDrug Therapy, CombinationFemaleHumansHydroxychloroquineIndolesInterferon beta-1aLopinavirMaleMiddle AgedRitonavirSulfidesAntiviral AgentsHydroxychloroquineIndolesInterferon beta-1aLopinavirRitonavirSulfidesumifenovirArbidolCOVID-19SARS-CoV-2Umifenovir

Identifiers

PMID34273635
PMCPMC8270750
OpenAlexW3178890688

What OpenQuestion holds

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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.