Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Danderyd Hospital | OTHER |
| Karolinska University Hospital | OTHER |
| Karolinska Institutet | OTHER |
Not provided
Not provided
Not provided
Not provided
Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicates that it is safe and effective for treatment of COVID. However, data is limited to small studies and case series on severely ill patients.
In a preliminary safety study 10 patients with severe COVID-19, defined as requiring supplementary oxygen, having fever and a duration of illness less than 11 days were treated with 200 ml of CP. CP was given as a slow infusion without obvious adverse events. Eight patients had viremia. One patient rapidly cleared the virus and recovered following CP treatment. CP infusion did not appear to clear viremia in 7/8 patients. Five of these were eventually admitted to ICU. Thus CP did not appear to cause acute toxicity but did not seem to be effective at the dose used. Viremia seemed to be a marker of a high risk of disease progression The proposed study thus aims to treat a high risk population identified by having viremia irrespective of but hopefully before they develop pulmonary injury such that they require supplementary oxygen therapy. Moreover the dose of plasma will be increased incrementally with the aim of clearing viremia as our initial study indicates that continued viremia is driving COVID-19.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Convalescent plasma treatment | Experimental | Participants will receive 200 ml convalescent plasma daily until SARS-CoV-2 is no longer detectable in the blood up to a maximum of 7 CP infusions. CP will be given as a slow infusion over 1 hour. Patients will be monitored for adverse events, especially allergic reactions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 convalescent plasma | Biological | Treatment with convalescent plasma (200ml, up to a maximum of 7 CP infusions). Plasma from consenting individuals who have recovered from SARS-CoV-2 infection. |
| Measure | Description | Time Frame |
|---|---|---|
| Number and proportion of patients with progression to ventilation or sustained requirement of supplementary oxygen therapy | Progression to non-invasive or invasive ventilation or a sustained requirement of 15L of supplementary oxygen therapy in patients that are not eligible for intensive care treatment. | Measured in the first 28 days after inclusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse reactions and serious adverse reactions. The safety of the intervention will be assessed with regard to AEs, baseline medical conditions, and findings from the physical examination and laboratory tests. Possible adverse events will be elicited using a modification and Swedish translation (appendix 6) of Common Terminology Criteria for Adverse Events v5.0 and they will be continuously reported to the sponsor. Adverse events related to convalescent plasma therapy shall be followed to assess reversibility. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johan Ursing, MD, PhD | Danderyd Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danderyd Hospital | Danderyd | Stockholm County | 18257 | Sweden | ||
| Karolinska University Hospital |
The investigators will be sharing the data, but the management plan is being designed.
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000093522 | COVID-19 Serotherapy |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
Not provided
Not provided
An open, non-randomised controlled, safety and dose identifying clinical trial
Not provided
Not provided
Not provided
Not provided
| The reporting period for AEs starts at inclusion and ends at the final follow-up visit 2 months after inclusion. |
| Dose of plasma needed to clear viremia | Measured as doses of convalescent plasma administered (1-7 infusions, 200ml). | 28 days |
| Clearance of viremia | SARS-CoV-2 RNA detection by PCR in blood or serum. Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months. | 6 months. |
| Fever and symptoms | Time to resolution of fever and symptoms. Breathing rate, peripheral oxygen saturation (measured with pulse oximetry after 20 minutes of rest), oxygen use, pulse, blood pressure, body temperature and mental state will be monitored 3 times/day while hospitalized. | Until discharged from the hospital, up to 2 months |
| Inflammatory parameters | Time to normalization of inflammatory parameters. Blood samples for inflammatory parameters will be taken daily until normalized or discharged from the hospital. | Until discharged from the hospital, up to 2 months |
| Antibody response to SARS-CoV-2 | Characterization of the antibody response to SARS-CoV-2. Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months. | 6 months |
| Stockholm |
| 14186 |
| Sweden |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D056747 |
| Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |