Evidence map›Paper›PMID 35514201›Full record

Trial reportAmerican journal of reproductive immunology (New York, N.Y. : 1989)2022

Complement blockade with eculizumab for treatment of severe Coronavirus Disease 2019 in pregnancy: A case series.

Richard M Burwick, Gabriela Dellapiana, Rachel A Newman, Sarah D Smithson, Mariam Naqvi, John Williams, Melissa S Wong, Martha Bautista, Anna Gaden, Shamsah D Kazani and 9 more

Registry-linked trialOpen access · hybridAbstract readClinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of reproductive immunology (New York, N.Y. : 1989), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04355494 (SOLIRIS®), which is not on this map. Cited by 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 pooled it
2.0field-weighted citation impact, top 14% 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.

NCT04355494 no longer availablenot on this map

SOLIRIS® (Eculizumab) for the Treatment of Participants With Coronavirus Disease 2019 (COVID 19) - An Expanded Access Program for Hospital-based Emergency Treatment

Typeexpanded_accessSponsorAlexion Pharmaceuticals, Inc.ConditionsCOVID-19, Pneumonia, Viral, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)Armseculizumab
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 3 syntheses or guidelines pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Review
  6. Article
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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

19 authors at 4 institutions in 2 countries.

Richard M BurwickDepartment of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, California, USA.ORCID 0000-0002-2340-3772
Gabriela DellapianaDepartment of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, California, USA.ORCID 0000-0003-3043-6959
Rachel A NewmanDepartment of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Sarah D SmithsonDepartment of Obstetrics and Gynecology, Loma Linda Medical Center, Los Angeles, California, USA.
Mariam NaqviDepartment of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, California, USA.
John WilliamsDepartment of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Melissa S WongDepartment of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Martha BautistaDepartment of Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Anna GadenDepartment of Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Shamsah D KazaniClinical Development & Translational Sciences, Alexion, AstraZeneca Rare Disease, Boston, Massachusetts, USA.
Derek A DunnClinical Development & Translational Sciences, Alexion, AstraZeneca Rare Disease, Boston, Massachusetts, USA.
Mark H MaBioanalytical and Biomarker Development, Alexion, AstraZeneca Rare Disease, Boston, Massachusetts, USA.
Sanjay MitterBiostatistics - Quantitative Sciences, Alexion, AstraZeneca Rare Disease, Boston, Massachusetts, USA.
Jonathan P R MonteleoneClinical Development & Translational Sciences, Pharmacometrics, Alexion, AstraZeneca Rare Disease, Boston, Massachusetts, USA.
Stephan R OrtizClinical Development & Translational Sciences, Clinical Pharmacology, Alexion, AstraZeneca Rare Disease, Boston, Massachusetts, USA.
Sara GhandehariDepartment of Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Noah MerinDepartment of Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Mark I ZakowskiDepartment of Anesthesiology, Cedars-Sinai Medical Center, Los Angeles, California, USA.ORCID 0000-0001-5677-1355
S Ananth KarumanchiDepartment of Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Cedars-Sinai Medical Center · USAlexion Pharmaceuticals (United States) · USAstraZeneca (United States) · USLoma Linda University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

problemWe evaluated eculizumab, a complement protein C5 inhibitor, for treatment of severe COVID-19 in pregnant and postpartum individuals. METHOD OF STUDY: Protocol ECU-COV-401 (clinicaltrials.gov NCT04355494) is an open label, multicenter, Expanded Access Program (EAP), evaluating eculizumab for treatment of severe COVID-19. Participants enrolled at our center from August 2020 to February 2021. Hospitalized patients were eligible if they had severe COVID-19 with bilateral pulmonary infiltrates and oxygen requirement. Eculizumab was administered on day 1 (1200 mg IV) with additional doses if still hospitalized (1200 mg IV on Days 4 and 8; 900 mg IV on Days 15 and 22; optional doses on Days 12 and 18). The primary outcome was survival at Day 15. Secondary outcomes included survival at Day 29, need for mechanical ventilation, and duration of hospital stay. We evaluated pharmacokinetic and pharmacodynamic data, safety, and adverse outcomes.

resultsEight participants were enrolled at the Cedars-Sinai Medical Center, six during pregnancy (mean 30 ± 4.0 weeks) and two in the postpartum period. Baseline oxygen requirement ranged from 2 L/min nasal cannula to 12 L/min by non-rebreather mask. The median number of doses of eculizumab was 2 (range 1-3); the median time to hospital discharge was 5.5 days (range 3-12). All participants met the primary outcome of survival at Day 15, and all were alive and free of mechanical ventilation at Day 29. In three participants we demonstrated that free C5 and soluble C5b-9 levels decreased following treatment. There were no serious adverse maternal or neonatal events attributed to eculizumab at 3 months.

conclusionWe describe use of eculizumab to treat severe COVID-19 in a small series of pregnant and postpartum adults. A larger, controlled study in pregnancy is indicated.

Indexed as

Antibodies, Monoclonal, HumanizedCOVID-19 Drug TreatmentAdultComplement System ProteinsFemaleHumansInfant, NewbornOxygenPregnancySARS-CoV-2Treatment OutcomeAntibodies, Monoclonal, HumanizedComplement System ProteinseculizumabOxygencomplement system proteinsCOVID-19eculizumabpregnancy

Identifiers

PMID35514201
PMCPMC9347938
OpenAlexW4229054354

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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 Socratic graph.