COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05142306

Gideon Akintunde

Not reported

2021-12-02

Completed

RCT

Randomized

Parallel

Open label

multi-center

Prevention

inclusion criteria: able and willing to provide written informed consent (voluntarily signed by the participant) prior to performing study procedures. females and males 18-59 years of age. have a body mass index (bmi) less than or equal to 35.0 kg/m^2 healthy, based on medical history (no chronic disease, no chronic therapy, no ongoing acute condition within four weeks prior to dosing), normal physical examination (no clinically significant findings in the opinion of the investigator), and screening laboratory assessments (no clinically significant findings in the opinion of the investigator). no clinical symptoms suspicious for covid-19 infection, as well as sars-cov-2 immunoglobulin m (igm) antibody negative and no laboratory evidence of current sars-cov-2 infection (i.e., reverse transcription polymerase chain reaction (rt-pcr) negative for sars-cov-2) at screening. females must not be pregnant, or trying to become pregnant as demonstrated by either of the following a or b: a. not of childbearing potential: surgically sterile (at least six weeks post bilateral salpingectomy, bilateral oophorectomy, or hysterectomy); or post-menopausal (history of ≥12 consecutive months without menses prior to randomization in the absence of other pathologic or physiologic causes and confirmed by follicle stimulating hormone [fsh] level ≥40 miu/ml) or b. women of childbearing potential who are not planning to be pregnant during the study period who meet all of criteria i-iii: i. negative serum pregnancy test at the screening visit. ii. negative urine pregnancy test on day 1 (a positive test will result in discontinuation from intervention). iii. using one of the following highly effective methods of contraception during the study: combined estrogen and progestogen, or progestogen-only hormonal contraception associated with inhibition of ovulation (e.g., implants, pills, patches) initiated ≥30 days prior to study day 1. intrauterine device (iud) or hormone releasing intrauterine system (ius) inserted ≥30 days prior to study day 1. participant understands and agrees to comply with planned study procedures.

use of any investigational product within 30 days or sars-cov-2 monoclonal antibodies and covid-19 convalescent plasma within 90 days prior to screening or anticipated receipt during the study follow-up period, or participant plans to participate in another clinic study during the study period. receipt of 1 or 2 doses covid-19 vaccine within 60 days prior to screening or during the study follow-up period. sars-cov-2 igg antibody levels >80 au/ml as determined by the diasorin liaison sars-cov-2 s1/s2 igg antibody assay. screening clinical laboratory test result greater than the laboratory's upper limit of normal (uln) for alanine aminotransferase (alt), aspartate aminotransferase (ast), random glucose, total and/or direct bilirubin, blood urea nitrogen (bun), or creatinine. other serum chemistry parameters that are not within the reference range will not be considered exclusionary unless deemed clinically significant by the principal investigator. positive laboratory evidence of current infection with human immunodeficiency virus (hiv), hepatitis c virus (hcv) or hepatitis b virus (hbv). note: positive anti-hcv antibody result along with a negative hcv pcr would not be exclusionary. history of allergy or hypersensitivity to blood or plasma products or to covid-hig excipients (proline, ps80). history of allergy to latex or rubber. history of hemolytic anemia. history of immunoglobulin a (iga) deficiency. receipt of any blood product within the past 12 months. plasma donation within 7 days or blood loss/donation (>450 ml) within 56 days of dosing. history of known congenital or acquired immunodeficiency or receipt of immunosuppressive therapy (e.g., prednisone or equivalent for more than two consecutive weeks within the past three months). history of thrombosis or hypercoagulable state with increased risk of thrombosis. receipt of a live vaccine within 30 days prior to screening or anticipated receipt of a live vaccine during the study period. currently pregnant, breastfeeding, or planning to become pregnant during the study. history of, or suspected substance abuse problem (including alcohol). any planned elective surgery or procedure during the follow-up period that impacts study compliance. other condition which may place participant at increased risk due to participation in the study or may impact study compliance as determined by the investigator. an opinion of the investigator (or designee) that it would not be in the best interest of the individual to participate in the study.

3

Emergent BioSolutions

18

59

United States

Healthy volunteers

N/A

23

Participants With Adverse Events (AEs) up to 72 Hours Post-dosing;Participants With Adverse Events That Led to Discontinuation or Temporary Suspension of Study Treatment;Participants With AEs and SAEs After Study Treatment;Pharmacokinetics Parameter of Area Under the Concentration-time (AUC) From Time 0 to Infinity (AUC0-inf) After Dose of COVID-HIGIV;Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-last) of SARS-CoV-2 Antibodies After Dose of COVID-HIG;Pharmacokinetics Parameter of Maximum Observed Concentration (Cmax) of SARS-CoV-2 Antibodies Observed After Dose of COVID-HIG;Pharmacokinetics Parameter of Time at Which Cmax Occurs After Dose of COVID-HIG;Pharmacokinetics Parameter of Trough Concentration of SARS-CoV-2 Antibodies Observed 28 Days After Dose (Cmin28d) of COVID-HIG;Total Number of AEs and SAEs After Study Treatment

None

Phase 1

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