Intravenous immunoglobulin rich in neutralising antibodies to SARS-CoV-2 (COVID-19) as a passive immunity modality in healthy individuals: an open-label, active control Phase 1/2 Study

Phase 1

Recruiting

• Conditions: COVID-19; Inflammatory and Immune System - Other inflammatory or immune system disorders; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12620001249943
• Lead Sponsor: Aegros Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-20
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Adult participants 18 years and over at the time of consent
2. Healthy adults or adults with pre-existing medical conditions who are in a stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 3 months before enrolment
3. Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment
4. Willing and able to adhere to follow-up schedule
5. Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
• Has a negative pregnancy test at Screening and on Day 1.
• Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1.
• Has agreed to continue adequate contraception throughout the study period Day 1 to Day 42.
• Is not currently breastfeeding.
Adequate female contraception is defined as consistent and correct use of a Therapeutic Goods Administration (TGA) approved contraceptive method in
accordance with the product label. For example:
• Abstinence, where abstinence is the preferred and usual lifestyle of the participant
• Double barrier method (a condom and one other method of adequate contraception)
• Hormonal methods associated with inhibition of ovulation.
Acceptable hormonal methods include: oral contraceptives, contraceptive medication patch, contraceptive medication injection, estrogen / progestin vaginal ring, or contraceptive medication implant.
• Intrauterine device
• Sterilisation of a female participant’s monogamous male partner (with medical assessment of surgical success) prior to entry into the study
Note: periodic abstinence (e.g. calendar, ovulation, symptom-thermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
6. Male participants with female partners planning pregnancy should follow adequate contraception for the entire study period Day 1 to Day 42.

Exclusion Criteria

1.Is acutely ill or febrile 72 hours prior to or at Screening. Fever is defined as a body temperature greater than or equal to 37.5°C. Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
2.Concurrent, diagnosed, viral or bacterial infections that in the investigator’s opinion should exclude their participation.
3.Current infection with SARS-CoV-2 (positive result with either rapid antigen or PCR test)
4.Known infection with SARS-CoV-2 and resolution of symptoms within the last 60 days.
5.Vaccination against COVID-19 within the last 60 days.
6.Anti-SARS-CoV-2 anti-spike antibody level greater than or equal to 5000 AU per the Abbott AdviseDx SARS CoV-2 IgG II assay (or equivalent)
7.Anti-SARS-CoV-2 anti-nucleocapsid level above positive cut off level of 50 AU per the Abbott ARCHITECT SARS CoV-2 IgG assay (or equivalent).
8.Planned simultaneous participation in another interventional study to prevent or treat COVID-19.
9.Planned administration of any vaccine, including any type of COVID-19 vaccine, is not permitted until completion of the Week 6 (day 42+/-3) visit.
10.Proven hypersensitivity or allergic reaction to blood products or immunoglobulins or sodium citrate
11.Selective IgA deficiency (less than 70 mg/dL)
12.Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids greater than or equal to 20 mg/day of prednisone equivalent).
13.Immunosuppressive or immunodeficient state, asplenia, recurrent severe infections
14.Has received systemic immunoglobulins or blood products within 3 months prior to the day of screening.
15.Has participated in an interventional clinical study within 28 days prior to the day of enrolment.
16.Pregnant or breastfeeding.
17.Inability to adhere to follow up schedule
18.Not a suitable volunteer in the opinion of the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified