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| Column | Value |
|---|---|
| Trial registration number | NCT04730401 |
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Full text link
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2021-01-29 |
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Recruitment status
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : March 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - acute covid-19 disease at the time of recruitment laboratory-confirmed by upper respiratory tract pcr - patient recently (0-4 days earlier) admitted to hospital due to covid-19 infection - symptom onset 10 days before recruitment (if symptom onset unknown the duration is calculated from positive pcr-test) - the day should be recorded from the duration of the covid-19 symptoms/positive test result - the dose of lmwh thromboprofylaxis should be recorded - written informed consent. |
|
Exclusion criteria
Last imported at : March 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
- chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of imp; oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded ( inhaled or topical steroids allowed) - regular (daily), systemic administration of corticosteroids at the time on inclusion (inhaled or topical corticosteroids are allowed) - any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. - pregnancy or lactation. - alcohol or drug abuse. - suspected non-compliance. - presence of vte, including pulmonary embolism or other manifestations of thrombosis - use of any investigational drug (other than hydroxychloroquine) or vaccine within 30 days prior to first dose of study vaccine or planned use during study period. - any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction as judged by investigator. - known immunoglobulin a (iga) deficiency - existing treatment limitations: do-not-resuscitate (dnr) order or withholding treatment in icu - any other criteria which, as judged by investigator, might compromise a patient's well-being or ability to participate in the study or its outcome. - active malignant disease - cp not available for patients blood type - patient cannot assign written consent - no personnel available for cp of placebo transfusion |
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Number of arms
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Helsinki University Central Hospital |
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Inclusion age min
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Finland |
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Type of patients
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Moderate/severe/critical disease at enrollment |
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Severity scale
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
5: Moderate/severe/critical disease at enrollment |
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Total sample size
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
390 |
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primary outcome
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
Rate of intubation or systemic corticosteroids initiation;Safety (SAE);Safety (SAE) |
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Notes
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2 |
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Arms
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Low-titre", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "High-titre", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |