Comparison of The Therapeutic Effect of Convalescent Plasma and Plasma-derived Immunoglobulin-enriched solution on COVID-19 Patients

• Register: IRCT
• Last refreshed on: 21 April 2020
• Main ID: IRCT20200310046736N1
• Date of registration: 2020-04-01
• Prospective Registration: Yes
• Primary sponsor: Ahvaz University of Medical Sciences
• Public title: Comparison of The Therapeutic Effect of Convalescent Plasma and Plasma-derived Immunoglobulin-enriched solution on COVID-19 Patients
• Scientific title: Comparison of The Therapeutic Effect of Convalescent Plasma and Plasma-derived Immunoglobulin-enriched solution on COVID-19 Patients: A Clinical Trial Study
• Date of first enrolment: 2641-06-14
• Target sample size: 45
• Recruitment status: Pending
• URL: http://en.irct.ir/trial/46424
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple randomization with a random digit table, Blinding description: _ Participants are blinded to the details of the treatment process. _ Investigators (including Outcome assessor and Data analyzer) are blinded to knowing who is being given the treatment and who is not, and only receive the Patient's data and lab results from a physician as three subgroups A & B & C. But they don't know which are controls and or intervention groups! _ The care provider (an expert physician) will randomly divide patients into 2 groups [controls, and 2 subgroups], and then do the intervention treatment. Only he knows which subgroup belongs to controls, or intervention.
• Phase: 2-3

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Mandana Puladzadeh
• Affiliation: Ahvaz University of Medical Sciences

• Name: Mehdi Safdarian
• Affiliation: Ahvaz University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: COVID-19 Patients who have the clinical signs of COVIDE-19 infection such as fever, cough, sputum production, sore throat, and so on.
Patients with the positive CT scan
Patients who declare Informed Consent for this study.
Exclusion criteria: Pregnant Women (based on WHO protocol)
Lactating Women (based on WHO protocol)
Individuals who exhibit specific allergic reactions to intravenous administration.
Patients with/or with a history of dangerous underlying diseases such as IgA deficiency
Patients with/or with a history of dangerous diseases such as cardiovascular and or hematological disorders (hemophilia, thalassemia, leukemia).
Patients with/or with a history of underlying diseases such as liver and kidney disease
Smokers

Age minimum: 20 years
Age maximum: 45 years
Gender: Both

Health Condition(s) or Problem(s) studied

B97.29

COVIDE-19.
Other coronavirus as the cause of diseases classified elsewhere

Intervention(s)

Intervention 1: In this intervention group COVID-19 patients who do not reply to routine treatments and are in a critical stage and prolonged hospitalization will be treated with convalescent plasma (obtained from fully recovered patients according to inclusion criteria) {200 cc/day intravenous (IV) administration for 1 to 4 hours} for 1-4 days. Intervention 2: The second intervention group will be treated with Plasma-derived Immunoglobulin-enriched solution {IV, 0.2 _0.4 g/kg/day based on the patient's physiological tolerance}. Intervention 3: The control group will only receive routine care without any new therapeutic interventions.

Primary Outcome(s)

Negative result for COVID-19 RT-PCR test. Timepoint: About 7-14 days after starting the treatment. Method of measurement: Results of qRT-PCR test.

Primary outcome: complete remission of clinical signs of disease. Timepoint: About one week after starting the treatment. Method of measurement: Clinical and laboratory questionnaire.

Normal CT Scan. Timepoint: About 7-14 days after starting the treatment. Method of measurement: Result of CT scan.

Secondary Outcome(s)

Recovery and normal levels of biomarkers associated COVID-19. Timepoint: At least 1 to 2 weeks after treatment. Method of measurement: Laboratory Techniques.

Source(s) of Monetary Support

Ahvaz University of Medical Sciences

Secondary Sponsor(s)

Ahvaz University of Medical Sciences

Ethics review

Status: Approved
Approval date: 24/03/2020
Contact:

Ethics Committee of University Research, Ahvaz Jundishapur University of Medical Sciences, School of