Fluvoxamine for the treatment of COVID-19 - Kölner UniversitätsPublikationsServer

Nyirenda, John L. Z., Sofroniou, Mario, Toews, Ingrid, Mikolajewska, Agata, Lehane, Cornelius, Monsef, Ina, Abu-taha, Aesha, Maun, Andy ORCID: 0000-0002-9213-6583, Stegemann, Miriam and Schmucker, Christine ORCID: 0000-0002-1188-3158 (2022). Fluvoxamine for the treatment of COVID-19. Cochrane Database Syst Rev. (9). HOBOKEN: WILEY. ISSN 1361-6137

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DOI:10.1002/14651858.CD015391

Abstract

Background Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) that has been approved for the treatment of depression, obsessive compulsive disorder, and a variety of anxiety disorders; it is available as an oral preparation. Fluvoxamine has not been approved for the treatment of infections, but has been used in the early treatment of people with mild to moderate COVID-19. As there are only a few effective therapies for people with COVID-19 in the community, a thorough understanding of the current evidence regarding the efficacy and safety of fluvoxamine as an anti-inflammatory and possible anti-viral treatment for COVID-19, based on randomised controlled trials (RCTs), is needed. Objectives To assess the efficacy and safety of fluvoxamine in addition to standard care, compared to standard care (alone or with placebo), or any other active pharmacological comparator with proven efficacy for the treatment of COVID-19 outpatients and inpatients. Search methods We searched the Cochrane COVID-19 Study Register (including Cochrane Central Register of Controlled Trials, MEDLINE, Embase, ClinicalTrials.gov, WHO ICTRP, medRxiv), Web of Science and WHO COVID-19 Global literature on COVID-19 to identify completed and ongoing studies up to 1 February 2022. Selection criteria We included RCTs that compared fluvoxamine in addition to standard care (also including no intervention), with standard care (alone or with placebo), or any other active pharmacological comparator with proven efficacy in clinical trials for the treatment of people with confirmed COVID-19, irrespective of disease severity, in both inpatients and outpatients. Co-interventions needed to be the same in both study arms. We excluded studies comparing fluvoxamine to other pharmacological interventions with unproven efficacy. Data collection and analysis We assessed risk of bias of primary outcomes using the Cochrane Risk of Bias 2 tool for RCTs. We used GRADE to rate the certainty of evidence to treat people with asymptomatic to severe COVID-19 for the primary outcomes including mortality, clinical deterioration, clinical improvement, quality of life, serious adverse events, adverse events of any grade, and suicide or suicide attempt. Main results We identified two completed studies with a total of 1649 symptomatic participants. One study was conducted in the USA (study with 152 participants, 80 and 72 participants per study arm) and the other study in BraziE (study with 1497 high-risk participants for progression to severe disease, 741 and 756 participants per study arm) among outpatients with mild COVID-19. Both studies were double-blind, placebo controlled trials in which participants were prescribed 100 mg fluvoxamine two or three times daily for a maximum of 15 days. We identified five ongoing studies and two studies awaiting classification (due to translation issues, and due to missing published data). We found no published studies comparing fluvoxamine to other pharmacologica interventions of proven efficacy. We assessed both included studies to have an overall high risk of bias. Fluvoxamine for the treatment of COVID-19 in inpatients We did not identify any completed studies of inpatients. Fluvoxamine for the treatment of COVID-19 in outpatients Fluvoxamine in addition to standard care may slightly reduce all-cause mortality at day 28 (RR 0.69, 95% Cl 0.38 to 1.27; risk difference (RD) 9 per 1000; 2 studies, 1649 participants; low-certainty evidence), and may reduce clinical deterioration defined as all-cause hospital admission or death before hospital admission (RR 0.55, 95% CI 0.16 to 1.89; RD 57 per 1000; 2 studies, 1649 participants; low-certainty evidence). We are very uncertain regarding the effect of fluvoxamine on serious adverse events (RR 0.56, 95% CI 0.15 to 2.03; RD 54 per 1000; 2 studies, 1649 participants; very low-certainty evidence) or adverse events of any grade (RR 1.06, 95% CI 0.82 to 1.37; RD 7 per 1000; 2 studies, 1649 participants; very low-certainty evidence). Neither of the studies reported on symptom resolution (clinical improvement), quality of life or suicide/suicide attempt. Authors' conclusions Based on a low-certainty evidence, fluvoxamine may slightly reduce all-cause mortality at day 28, and may reduce the risk of admission to hospital or death in outpatients with mild COVID-19. However, we are very uncertain regarding the effect of fluvoxamine on serious adverse events, or any adverse events. In accordance with the living approach of this review, we will continually update our search and include eligible trials as they arise, to complete any gaps in the evidence.

Item Type:

Journal Article

Creators:

Creators	Email	ORCID	ORCID Put Code
Nyirenda, John L. Z.	UNSPECIFIED	UNSPECIFIED	UNSPECIFIED
Sofroniou, Mario	UNSPECIFIED	UNSPECIFIED	UNSPECIFIED
Toews, Ingrid	UNSPECIFIED	UNSPECIFIED	UNSPECIFIED
Mikolajewska, Agata	UNSPECIFIED	UNSPECIFIED	UNSPECIFIED
Lehane, Cornelius	UNSPECIFIED	UNSPECIFIED	UNSPECIFIED
Monsef, Ina	UNSPECIFIED	UNSPECIFIED	UNSPECIFIED
Abu-taha, Aesha	UNSPECIFIED	UNSPECIFIED	UNSPECIFIED
Maun, Andy	UNSPECIFIED	orcid.org/0000-0002-9213-6583	UNSPECIFIED
Stegemann, Miriam	UNSPECIFIED	UNSPECIFIED	UNSPECIFIED
Schmucker, Christine	UNSPECIFIED	orcid.org/0000-0002-1188-3158	UNSPECIFIED