Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04941105 | Impact of PCSK9 Inhibition on Clinical Outcome in Patients During the Inflammatory Stage of the COVID-19 | PHASE3 | COMPLETED | 60 | — | — | Jun 1, 2021 | May 17, 2022 | Apr 21, 2023 | 1 | Poland |
Indication for intubation determined individually for each patient and clinical status
| Arm | Type | Description |
|---|---|---|
| PCSK9 inhibitor (evolocumab) | EXPERIMENTAL | 140 mg of evolocumab as a single subcutaneous injection and standard of care accordance to the latest recommendations |
| Usual Care | PLACEBO_COMPARATOR | 1 ml of 0,9% saline solution as a single subcutaneous injection. Patients will be treated in accordance to the latest recommendations on caring for patients infected with SARS-CoV-2. |
| Name | Type | Description |
|---|---|---|
| Evolocumab | DRUG | A single subcutaneous administration of 140 mg evolocumab |
| Saline solution | DRUG | A single subcutaneous injection of 1ml of 0,9% saline solution |
Inclusion Criteria: 1. Written informed consent for participation in the study 2. Male and female age 18 or more at the time of signing the informed consent 3. SARS-CoV-2 infection confirmed by Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) 4. COVID-19 pneumonia with a typical r...