Clinical trial NCT04441424: Convalescent Plasma Therapy on Critically-ill Novel Coronavirus (COVID-19) Patients
Official title: The Therapeutic Potential of Convalescent Plasma Therapy on Treating Critically-ill COVID-19 Patients Residing in Respiratory Care Units in Hospitals in Baghdad, Iraq
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IMMUNOTHERAPY
Lead sponsor: Alkarkh Health Directorate-Baghdad
Sponsor class: OTHER_GOV
First posted: 2020-06-22
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Out of 49 early-stage critically-ill COVID-19 patients, 21 patients are the experimental group who take convalescent plasma compared to 28 patients receive only conventional therapy without taking Convalescent plasma. Recovery or death, length of stay in hospital, and improvement in the clinical course of the disease are monitored in relation to monitoring through severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) RNA detection via poly chain reaction (PCR), and SARS-CoV-2 immunoglobulin G (IgG) and immunoglobulin M (IgM) serological monitoring.

Detailed description: Objectives: The current COVID-19 pandemic needs unconventional therapies to tackle the resulted high morbidity and mortality. Convalescent plasma is one of the therapeutic approaches that might be of benefit. Methods: Forty nine early-stage critically-ill COVID-19 patients residing in respiratory care units (RCU) of three hospitals in Baghdad, Iraq were included, 21 received convalescent plasma while 28 did not receive, namely control group. Recovery or death, length of stay in hospital, and improvement in the clinical course of the disease were monitored clinically along with laboratory monitoring through SARS-CoV-2 RNA detection via PCR, and SARS-CoV-2 IgG and IgM serological monitoring.

Eligibility criteria: Inclusion Criteria:

* 49 critically-ill COVID-19 patients are included.
* All of the patients were with pneumonia and residing in RCU
* Age ≥ 18 y
* With dyspnea and oxygen saturation less than 90% in resting state.
* At their first 3 days in RCU either receiving O2 therapy, c-pap, or on ventilators.
* All of the patients were residing in infectious diseases wards before being transferred to RCU.

Exclusion Criteria:

* The exclusion criteria of the COVID-19 patients were:

  * Previous allergic history to plasma or its ingredients such as sodium citrate.
  * Cases with serious general conditions, such as severe organ dysfunction, that are not suitable for transfusion.
  * Very late stage of the acute respiratory distress (ARDS) where Convalescent plasma (CP) has proved to be of low therapeutic benefit

Primary outcomes:
measure: Death versus survival of treated patients
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: The length of stay in hospitals
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Akarkh Healt hdirectorate
Study officials:
affiliation: Alkarkh health directorate
name: Ahmed S Abdulamir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, 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. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.