]>
IRCT20200310046736N1 IRCT 2020-04-01 Ahvaz University of Medical Sciences Comparison of The Therapeutic Effect of Convalescent Plasma and Plasma-derived Immunoglobulin-enriched solution on COVID-19 Patients Comparison of The Therapeutic Effect of Convalescent Plasma and Plasma-derived Immunoglobulin-enriched solution on COVID-19 Patients: A Clinical Trial Study 2641-06-14 anticipated 45 Pending https://irct.ir/trial/46424 interventional 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. 2-3 COVIDE-19. 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. Yes - There is a plan to make this available What will be shared: Clinical, Laboratory, and Demographic Data of COVID-19 Patients undergoing Convalescent Plasma Therapy and or Immunoglobulin therapy When: About 5 to 8 months after starting the study To whom: Public Conditions: Detailed study information can be provided to competent researchers interested in designing immunological vaccines. Where to obtain: Corresponding Author How to obtain: Competent & enthusiastic researchers can receive detailed data from the corresponding author after the publication of work and by providing their identifiable information. Comments: This Clinical Trial with the title of ''Comparison of The Therapeutic Effect of Convalescent Plasma and Plasma-derived Immunoglobulin-enriched solution on COVID-19 Patients: A Clinical Trial Study'' has not been previously registered and is not being concurrently submitted elsewhere. We are very pleased to register our Clinical Trial on the IRCT website (www.irct.ir). Thank you for your time and kindness. Best Health & Moments
public Mandana Puladzadeh
Ahvaz Jundishapur University of Medical Sciences, Golestan Blv. Ahvaz, IR Iran
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8283 parastoomoradi40@yahoo.com Ahvaz University of Medical Sciences scientific Mehdi Safdarian
Ahvaz Jundishapur University of Medical Sciences, Golestan Blv. Ahvaz, IR Iran
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3337 7435 msafdaryan@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) 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. 20 years 45 years Both 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 B97.29 Other coronavirus as the cause of diseases classified elsewhere Treatment - Drugs Treatment - Drugs Other 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. 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}. The control group will only receive routine care without any new therapeutic interventions. Primary outcome: complete remission of clinical signs of disease. Timepoint: About one week after starting the treatment. Method of measurement: Clinical and laboratory questionnaire. 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. Normal CT Scan. Timepoint: About 7-14 days after starting the treatment. Method of measurement: Result of CT scan. Recovery and normal levels of biomarkers associated COVID-19. Timepoint: At least 1 to 2 weeks after treatment. Method of measurement: Laboratory Techniques. Ahvaz University of Medical Sciences Ahvaz University of Medical Sciences Ahvaz University of Medical Sciences Approved 2020-03-24 Ethics Committee of University Research, Ahvaz Jundishapur University of Medical Sciences, School of Ahvaz Jundishapur University of Medical Sciences, School of Medicine, Department of Emergency Medicine Ahvaz Khouzestan Iran (Islamic Republic of)