NCT04530370

Brief Summary

The discovery of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the outbreak of coronavirus disease 2019 (COVID-19) are causing public health emergencies. A handful pieces of literature have summarized its clinical and radiologic features, whereas therapies for COVID-19 are rather limited. To evaluate the efficacy of convalescent plasma therapy in COVID-19 patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for early_phase_1 covid19

Timeline
Completed

Started May 2020

Shorter than P25 for early_phase_1 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

August 28, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

August 26, 2020

Last Update Submit

August 27, 2020

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Satisfactory outcome

    Patients' response to recovered Covid 19 plasma (RCP) during 5 days after transfusion, was our primary goal. It was categorized into either satisfactory or unsatisfactory outcomes. We defined satisfactory outcome as two or more of the following 4 conditions/ or otherwise unsatisfactory: 1. respiratory frequency \< 30/min, 2. Sustain blood oxygen saturation ≥93% on room air, 3. partial pressure of arterial oxygen to fraction of inspired oxygen ratio \> 300 mmHg, 4. Regression of pulmonary infiltrates occupying less than 50% of both lungs.

    5 days

Study Arms (2)

Recovered covid 19 plasma

EXPERIMENTAL
Biological: recovered covid 19 patients plasma

controlled

PLACEBO COMPARATOR
Biological: recovered covid 19 patients plasma

Interventions

recovered covid 19 patients plasmaBIOLOGICAL

we transfused 150 ml of recovered covid 19 plasma to severely ill patients with confirmed covid 19 disease

Recovered covid 19 plasmacontrolled

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients ≥ 18 years, with confirmed laboratory covid-19, and have one or more of the following 4 conditions:
  • \. respiratory frequency ≥ 30/min,
  • \. blood oxygen saturation ≤ 93% on room air,
  • \. partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300 mmHg,
  • \. pulmonary infiltrates occupying more than 50% of both lungs.

You may not qualify if:

  • Any patient with prior allergic history to plasma or
  • allergy to plasma products or
  • septic shock or
  • multiple organ failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Valley University

Qina, 83523, Egypt

RECRUITING

Related Publications (3)

  • Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.

    PMID: 37162745DERIVED

  • Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.

    PMID: 36734509DERIVED

  • Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.

    PMID: 34013969DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Gad s Gad, MD

    South Valley University

    STUDY CHAIR

Central Study Contacts

ossama h salman, MD,PhD

CONTACT

+201223001113ossamas@hotmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

August 26, 2020

First Posted

August 28, 2020

Study Start

May 29, 2020

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

August 28, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations

EG(1)