Convalescent Plasma Therapy on Critically-ill Novel Coronavirus (COVID-19) Patients

Alkarkh Health Directorate-Baghdad

Status: Completed

Conditions: IMMUNOTHERAPY

Treatments: Drug: Hydroxychloroquin with Azithromycin; Biological: Convalescent plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04441424

CPT-COVID-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Convalescent plasma group

Experimental group

Description:

21 critically-ill COVID-19 patients were given convalescent plasma: 400 ml of convalescent plasma from COVID-19 recovered subjects. The plasma infusion lasts for one hour.

Treatment:

Drug: Hydroxychloroquin with Azithromycin

Biological: Convalescent plasma

Control group

Other group

Description:

This group is 28 critically-ill COVID-19 patients who are at the same disease stage to those of experimental group that were treated with conventional therapy without taking convalescent plasma. The conventional therapy: 400 mg once PO Hydroxychloroquine/day with 250mg once PO Azithromycin.

Treatment:

Drug: Hydroxychloroquin with Azithromycin