Evidence map›Paper›PMID 36295001›Full record

ArticleLife (Basel, Switzerland)2022

Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients-An Open-Label Phase II Clinical Trial.

Rada M Grubovic Rastvorceva, Sedula Useini, Milena Stevanovic, Ilir Demiri, Elena Petkovic, Massimo Franchini, Daniele Focosi

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Life (Basel, Switzerland), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04397523 (Use of COVID-19 Convalescent Plasma in the Patients Infected With COVID-19), 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
0.2field-weighted citation impact, top 48% 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.

NCT04397523 nacompletednot on this map

Use of COVID-19 Convalescent Plasma in the Patients Infected With COVID-19 (SARS-CoV-2) - Efficacy and Safety

TypeinterventionalSponsorInstitute for Transfusion Medicine of RNMRan2020 to 2021Enrolled200ConditionsConvalescent Plasma, COVID-19, SARS-CoV 2Armsanti-SARS-CoV-2 convalescent plasma
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
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

7 authors at 3 institutions in 2 countries.

Rada M Grubovic RastvorcevaInstitute for Transfusion Medicine of RNM, 1000 Skopje, North Macedonia.ORCID 0000-0002-4885-3323
Sedula UseiniInstitute for Transfusion Medicine of RNM, 1000 Skopje, North Macedonia.
Milena StevanovicUniversity Clinic for Infectious Diseases, 1000 Skopje, North Macedonia.
Ilir DemiriUniversity Clinic for Infectious Diseases, 1000 Skopje, North Macedonia.
Elena PetkovicInstitute for Transfusion Medicine of RNM, 1000 Skopje, North Macedonia.
Massimo FranchiniDivision of Hematology, Caro Poma Hospital, 46100 Mantua, Italy.ORCID 0000-0002-8795-0580
Daniele FocosiNorth-Western Tuscany Blood Bank, Pisa University Hospital, 56124 Pisa, Italy.ORCID 0000-0001-8811-195X
Institute of public health of Republic of Macedonia · MKPHI University Psychiatric Clinic - Skopje · MKAzienda Ospedaliera Carlo Poma · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: COVID-19 convalescent plasma (CCP) is an important antiviral option for selected patients with COVID-19. Materials and Methods: In this open-label, phase 2, clinical trial conducted from 30 April 2020 till 10 May 2021 in the Republic of North Macedonia, we evaluated the efficacy and safety of CCP in hospitalized patients. Treatment was with a single unit of CCP having an anti-RBD IgG concentration higher than 5 AU/mL. Results: There were 189 patients that completed the study, of which 65 (34.4%) had WHO 8-point clinical progression scale score of 3 (requiring hospital care but not oxygen support), 65 (34.4%) had a score of 4 (hospitalized and requiring supplemental oxygen by mask or nasal prongs), and 59 (31.2%) had a score of 5 (hospitalized and requiring supplemental oxygen by non-invasive ventilation or high-flow oxygen). Mean age was 57 years (range 22−94), 78.5% were males, 80.4% had elevated body mass index, and 70.9% had comorbidity. Following CCP transfusion, we observed clinical improvement with increase rates in oxygenation-free days of 32.3% and 58.5% at 24 h and seven days after CCP transfusion, a decline in WHO scores, and reduced progression to severe disease (only one patient was admitted to ICU after CCP transfusion). Mortality in the entire cohort was 11.6% (22/189). We recorded 0% mortality in WHO score 3 (0/65) and in patients that received CCP transfusion in the first seven days of disease, 4.6% mortality in WHO score 4 (3/65), and 30.5% mortality in WHO score 5 (18/59). Mortality correlated with WHO score (Chi-square 19.3, p < 0.001) and with stay in the ICU (Chi-square 55.526, p ≤ 0.001). No severe adverse events were reported. Conclusions: This study showed that early administration of CCP to patients with moderate disease was a safe and potentially effective treatment for hospitalized COVID-19 patients. The trial was registered at clinicaltrials.gov (NCT04397523).

Indexed as

convalescent plasmaCOVID-19SARS-CoV-2

Identifiers

PMID36295001
PMCPMC9605182
OpenAlexW4303945890

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.