There is no vaccine, drugs or approved treatment for 2019-nCoV because it is not well known and emerging. In this a prospective, phase II trial study, we intend to evaluate the safety and efficacy of using convalescent plasma for passive immunotherapy in patients with 2019-nCoV infection.
This is a prospective, phase II trial study. Study will be done on patients who have severe pneumonia following 2019-nCoV infection and hospitalized in the ICU. Convalescent plasma will be used to treat patients.
Settings and conduct:
Eligible patients who hospitalized in the ICU of Taleghani hospital will candidate for receiving convalescent plasma. Plasma donors will be evaluated based on inclusion and exclusion criteria. An about of 600-900 ml plasma will be obtained from each donor by apheresis. Eligible patients will receive 2 to 3 times ABO-compatible convalescent plasma in final volume of 250-300 ml with 1-day interval.
Participants/Inclusion and exclusion criteria:
Inclusion criteria of plasma donor
Recovery from 2019-nCoV infection according to clinical and laboratory criteria
Negative RT-PCR test
Negative results of serum/plasma for HBV, HCV, HTLV, HIV, and Syphilis
Exclusion criteria of plasma donor
Active respiratory infection symptoms: cough, dyspnea, oxygen requirements
Fever during 3 days ago
Inclusion criteria of recipient
Positive 2019- nCoV infection by RT-PCR
Respiratory > 30 beats/min
PaO2 / FiO2 ≤300 mmHg
Exclusion criteria of recipient
Co-infection with other respiratory viral infection
convalescent plasma therapy in patients with COVID-2019
Main outcome variables:
Size of lesion area by Chest CT scan
Recovery of clinical symptoms such as fever and respiratory rate
All outcomes will be evaluated on day of 1, 4, 7,14, and 28 after treatment.