COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-001663-24/DK

CHIP, Rigshospitalet, University of Copenhagen - Jens Lundgren

jens.lundgren@regionh.dk

2021-07-25

Recruiting

RCT

Randomized

Adaptive

Blind label

multi-center

Treatment

1. Clinical risk based on age ≥ 55 years or an adult (age ≥ 18 years) with an immunosuppressed condition. 2. Positive test for SARS-CoV-2 within ≤5 days (if >1 test, the first positive is within ≤5 days). Tests may include an institutional-based nucleic acid amplification test (NAAT), or any protocol-approved rapid test. 3. Within ≤5 days from symptom onset, if symptomatic from current SARS-CoV-2 infection. 4. Agrees to not participate in another clinical trial for the treatment or management of SARS-CoV-2 infection through Day 7, or until hospitalized or significant disease progression if prior to Day 7 (defined by ordinal category 4 or 5). 5. Participant provides written informed consent prior to study procedures, and understands and agrees to adhere to planned study procedures through Day 28. Information on which patient populations may benefit most from passive immune strategies targeting SARS-CoV-2 are limited. However, patients with impaired immune responses, whether from an underlying condition or the result of medical treatments, may have a delayed and/or reduced endogenous antibody response during COVID-19. Ongoing immunosuppressive condition or immunosuppressive treatment, includes: Steroids equivalent to prednisone > 10 mg/day for at least the last 28 days Rheumatologic or autoimmune disorder treated with a biologic or non-biologic immunosuppressive therapy Antirejection medicine after solid organ or stem cell transplantation Cancer treatment with systemic chemotherapy, biologic and/or cell-based therapy in the last 12 months Primary or acquired severe B- or T-lymphocyte immune dysfunction HIV infection Splenectomy or functional asplenia

1. Asymptomatic and had prior symptoms from the current infection that have now resolved (for >24 hours). 2. Asymptomatic and has received a vaccination for COVID-19 (≥1 dose). 3. Undergoing evaluation for possible admission to hospital for medical management (this does not include evaluation of possible hospitalization for public health purposes). 4. Evidence of pneumonia and/or hypoxia due to COVID-19 (NOTE: chest imaging is not required, but if available it should not show new infiltrates suggestive of pneumonia, hypoxia is defined by new oxygen supplementation or increase above pre-illness level). 5. Prior receipt of immunoglobulin product or passive immune therapy for SARS-CoV-2 in the past 90 days (i.e., convalescent plasma, SARS-CoV-2 monoclonal antibodies, or any IVIG). 6. Any of the following thrombotic or procoagulant conditions or disorders: acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous thrombosis within 28 days of randomization. prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antiphospholipid syndrome, or a deficiency in antithrombin III, protein C, or protein S. 7. History of hypersensitivity to blood, plasma or IVIG excipients. 8. Known IgA deficiency or anti-IgA antibodies. 9. Medical conditions for which receipt of a 300 mL volume of IV fluid from study treatment may pose specific risk to the patient (e.g., decompensated congestive heart failure). 10. In the opinion of the investigator, any condition for which participation would not be in the best interest of the participant or that could prevent or confound protocol assessments.

3

Regents of the University of Minnesota

18

100

Argentina;Denmark;France;Germany;Greece;Israel;Japan;Mexico;Nigeria;Peru;Spain;Thailand;United Kingdom;United States

Mild disease at enrollment

1: Mild disease at enrollment

50

The goals of this study are to assess the safety and efficacy of a single infusion of hIVIG in preventing further progression related to COVID-19 when administered early after diagnosis and symptom onset (if symptomatic), with a further aim to concurrently assess for more rapid resolution of illness and restoration of health status to the pre-illness state. There is as yet no consensus on the optimal endpoint for determining clinical benefit from COVID-19 therapies in the ambulatory care setting, including the constituent elements of the endpoint and the timing of its assessment after a given treatment. The primary endpoint is the participant’s clinical status through Day 7, as defined by five mutually exclusive categories on an ordinal scale: 1. Asymptomatic and no limitations in usual activity due to COVID-19 2. Mild COVID-19 illness or minor limitations to usual activity 3. Moderate COVID-19 illness and major limitations to usual activity 4. Severe COVID-19 or other serious disease manifestation 5. Critical illness from COVID-19 or Death

nan

Phase 3

[{"arm_notes": "", "treatment_id": 1990, "treatment_name": "Np-028 hivig", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 610, "treatment_name": "Hyperimmune immunoglobulin to sars-cov-2 (hivig)", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]