NCT04764747

Brief Summary

Multicenter retrospective cohort study from June to August 2020 on hospitalized COVID-19 patients admitted to Al-Hakeem and Al-Amal hospital in Al-Najaf Governorate, Iraq, in order to evaluating the effectiveness of plasma therapy in hospitalized patients with COVID-19 and analyzing factors that affect therapeutic outcome, either related to patients or related to donors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

November 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2021

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

February 18, 2021

Last Update Submit

May 29, 2021

Conditions

Covid19

Outcome Measures

Primary Outcomes (3)

  • Time to clinical improvement

    modified six-point ordinal scale of COVID-19

    14 days

  • Find the prediction factors associated with good outcome of patients on CP therapy

    Demographic data and clinical parameters of patients associated with positive therapeutic outcome for CP measured as number of patients discharge from hospital with complete recovery (negative PCR for COVID-19). The association determined by univariate and multivariate analysis

    14 days

  • Time to negative PCR

    number of days required for patients to be have negative PCR (free viral load)

    14 days

Secondary Outcomes (3)

  • Mortality rate

    21 days

  • Hospital stay time

    21 days

  • Adverse effect of plasma therapy

    21 days

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patients diagnosed with COVID-19

You may qualify if:

  • Adult 18 years old or older.
  • COVID-19 confirmed by reverse transcriptase-polymerase chain reaction (RT-PCR).
  • hospitalized adult patients with COVID-19.

You may not qualify if:

  • Patients with history of alleragy to plasma transfusion.
  • Patients with history of autoimmune disease or selective IgA deficiency.
  • Patients with suspected coronavirus.
  • Patients with incomplete data in his record.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Al-Amal Hospital

Najaf, Iraq

Location

Al-Hakeem Hospital

Najaf, Iraq

Location

Related Publications (4)

  • Chauhan S. Comprehensive review of coronavirus disease 2019 (COVID-19). Biomed J. 2020 Aug;43(4):334-340. doi: 10.1016/j.bj.2020.05.023. Epub 2020 Jun 1.

    PMID: 32788071BACKGROUND

  • Li L, Zhang W, Hu Y, Tong X, Zheng S, Yang J, Kong Y, Ren L, Wei Q, Mei H, Hu C, Tao C, Yang R, Wang J, Yu Y, Guo Y, Wu X, Xu Z, Zeng L, Xiong N, Chen L, Wang J, Man N, Liu Y, Xu H, Deng E, Zhang X, Li C, Wang C, Su S, Zhang L, Wang J, Wu Y, Liu Z. Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial. JAMA. 2020 Aug 4;324(5):460-470. doi: 10.1001/jama.2020.10044.

    PMID: 32492084BACKGROUND

  • Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6.

    PMID: 32253318BACKGROUND

  • Farhat RM, Mousa MA, Daas EJ, Glassberg MK. Treatment of COVID-19: Perspective on Convalescent Plasma Transfusion. Front Med (Lausanne). 2020 Jul 28;7:435. doi: 10.3389/fmed.2020.00435. eCollection 2020.

    PMID: 32850916BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms.Ph. Zainab Hadi Ibadi

Study Record Dates

First Submitted

February 18, 2021

First Posted

February 21, 2021

Study Start

November 1, 2020

Primary Completion

April 25, 2021

Study Completion

April 25, 2021

Last Updated

June 2, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

IR(2)