NCT04383548.

Study name	Clinical study for efficacy of anti‐corona VS2 immunoglobulins prepared from COVID19 convalescent plasma prepared by VIPS mini‐pool IVIG medical devices in prevention of SARS‐CoV‐2 infection in high risk groups as well as treatment of early cases of COVID19 patients
Methods	Trial design: interventional, single‐arm, open‐label, clinical trial Sample size: 100 Setting: inpatients Country: Egypt Language: English Number of centres: NR
Participants	Inclusion criteria: Passive immunisation group (Group A) 20 high‐risk exposed people (HCPs) who are nasopharyngeal swab SARSCoV‐2 PCR‐negative and seronegative for SARS‐CoV‐2 IgM/IgG antibodies to receive prophylactic anti‐SARS‐CoV‐2 hyper immunoglobulin. Selected population can be both male and female with age range 21‐50 years 20 high‐risk people (HCPs) who are nasopharyngeal swab SARS‐CoV‐2 PCR negative and seronegative for SARS‐CoV‐2 IgM/IgG antibodies as control group. Selected population can be both male and female with age range 21‐50 years Patient group (group B) 30 patients with COVID‐19 disease and nasopharyngeal swab or sputum SARS‐CoV‐2‐positive PCR to receive anti‐SARS‐CoV‐2 in addition to applied clinical management protocol. Selected test group can be male or female with age > 20 years 30 patients with COVID‐19 disease and nasopharyngeal swab or sputum SARS‐CoV‐2 PCR‐positive managed according to applied clinical management protocols of COVID‐19 disease as control group. Selected test group can be male or female with age > 30 years Exclusion criteria: Passive immunisation group (Group A) Age < 21 or > 50 years Nasopharyngeal swab SARS‐CoV‐2‐positive PCR Presence of anti‐SARS‐CoV‐2 IgM, IgG Presence of comorbidities such as hypertension, diabetes, chronic renal disease, previous thrombotic events or states of allergy such as urticaria or bronchial asthma as well as previous AEs due to infusion of IVIG Patient group (group B) Age < 20 years SARS‐CoV‐2 PCR‐negative COVID‐19 patients who may suffer from co‐morbidities such as hypertension, diabetes, chronic renal disease, thrombotic tendency or history of AEs to IVIG as well as old age will be excluded to reduce the possibility of development of SAEs related to infusion of IVIG unless it will be for compassionate use in advanced stages of COVID‐19 patients and after obtaining informed consent
Interventions	Intervention(s): hyper immunoglobulin Details of CP: Type of plasma: hyperimmune globulin ‐ prepared from CP using VIPS Mini‐Pool IVIG medical device Volume: NR Number of doses: NR Antibody‐titre: NR Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): NR Comparator: NA Concomitant therapy: NR Treatment cross‐overs: NA
Outcomes	Primary study outcome: efficacy of COVID19 hyper immunoglobulins for patients Primary review outcomes reported All‐cause mortality at hospital discharge: NR Time to death: NR Secondary review outcomes reported Number of participants with grade 3 and grade 4 AEs, including potential relationship between intervention and adverse reaction (e.g. TRALI, transfusion‐transmitted infection, TACO, TAD, acute transfusion reactions): yes Number of participants with SAEs: NR Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: NR 30‐day and 90‐day mortality: NR Admission on the ICU: NR Length of stay on the ICU: NR Time to discharge from hospital: NR QoL: NR Additional study outcomes: NR
Starting date	1 June 2020
Contact information	Contact: Alshaimaa M Selim, specialist 01003580480 shaimaamokhtargood@yahoo.com Contact: Maha A Mohamed, Professor 01000004572 atwa_maha@yahoo.com
Notes	Recruitment status: not yet recruiting Prospective completion date: 1 January 2021 Sponsor/funding: Assiut University