18 and older, any sex, with SARS CoV 2 Infection. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Patients With Treatment-emergent Adverse Events, Serious Adverse Events, and Adverse Events of Specific InterestPrimary· 36 weeks after the second dose of sotrovimab
Proportion of patients with treatment-emergent adverse events, serious adverse events, and adverse events of specific interest (including infusion-related and hypersensitivity reactions, anti-drug antibody (ADA) levels, and antibody-dependent enhancement
Proportion of subjects with treatment-emergent grade 3-4 adverse events, per DAIDS grading criteria.
Group
Value
95% CI
Sotrovimab
28
Proportion of study subjects with treatment-emergent serious adverse events (SAE).
Group
Value
95% CI
Sotrovimab
27
Proportion of study subjects with infusion-related and hypersensitivity reactions
Group
Value
95% CI
Sotrovimab
3
Proportion of study subjects with the development of antidrug antibody (ADA) levels
Group
Value
95% CI
Sotrovimab
3
Proportion of subjects with antibody-dependent enhancement (ADE)
Group
Value
95% CI
Sotrovimab
0
Half-life of Sotrovimab in Immunocompromised Patients With Impaired Humoral Immunity Against SARS-CoV-2.Primary· Within 1 hour of the first dose infusion of sotrovimab and on day 11, 29, and 59. Prior to the second dose, within 1 hour of the second dose infusion of sotrovimab, and 11, 29, 59, and 168 days after
Evaluation of half-life of sotrovimab in immunocompromised patients with impaired humoral immunity against SARS-CoV-2.
Group
Value
95% CI
Sotrovimab
67.7
47.3 – 95.8
COVID-19-related OutcomesSecondary· 36 weeks after the second dose of sotrovimab
The proportion of study subjects who: (a) develop COVID-19 (of any severity), (b) severe COVID-19, (c) Emergency department (ED) visits, inpatient hospitalization, or ICU hospitalizations within 28 days of a new diagnosis of SARS-CoV-2, (d) need for new or increasing supplemental oxygen or mechanical ventilation within 28 days of a new diagnosis of SARS-CoV-2, and (e) death due to any cause during the study follow-up period.
Patients who developed COVID-19 (of any severity)
Group
Value
95% CI
Sotrovimab
35
Patients who developed severe COVID-19
Group
Value
95% CI
Sotrovimab
1
General Health Quality of Life MeasurementSecondary· At treatment day 1, at treatment day 2
Health-related quality of life was assessed using the 36-Item Short Form Survey (SF-36), specifically focusing on the General Health domain. Each question in this domain was scored as follows:
For questions 33 and 35, responses were scaled: 1 = 0, 2 = 25, 3 = 50, 4 = 75, and 5 = 100.
For questions 1, 34, and 36, responses were scaled: 1 = 100, 2 = 75, 3 = 50, 4 = 25, and 5 = 0.
The scores for these five questions were summed to create a composite General Health score, with possible total scores ranging from 0 (indicating the best perceived general health) to 500 (indicating the worst percei
Group
Value
95% CI
Sotrovimab
-0.60
± 3.27
In Patients Who Develop COVID-19, the Greatest Extent of COVID-19 Symptoms, as Assessed Using the 8-point National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS)Secondary· from covid day 1 to end of hospitalization or covid day 14
National Institute of Allergy and Infectious Disease Ordinal Scale (NIAD-OS) was assessed at the end of hospitalization or 14 days after the diagnosis of COVID-19. The worst reported scale value was used in the analysis to adequately represent the greatest extent of their COVID-19 infection.
NIAID-OS Scale Value Description
1. Not hospitalized, no limitations on activities
2. Not hospitalized, limitation on activities or/or requiring home oxygen
3. Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care
4. Hospitalized, not requiring supplemental oxygen
5. Ho
Group
Value
95% CI
Sotrovimab
1
1 – 5
Number of Participants With New Cellular or Antibody-mediated Rejection EventsSecondary· 36 weeks after the second dose of sotrovimab
Assessment of rates of new cellular or antibody-mediated rejection events in solid organ transplant (SOT) recipients exposed to sotrovimab.
Group
Value
95% CI
Sotrovimab
0
New-onset or Worsening Graft-versus-host Disease in Hematopoietic Cell Transplant RecipientsSecondary· 36 weeks after the second dose of sotrovimab
Assessment of rates of new-onset or worsening graft-versus-host disease in hematopoietic cell transplant (HCT) recipients exposed to sotrovimab.
Group
Value
95% CI
Sotrovimab
0
New-onset Allograft or Stem Cell Failure Requiring Retransplantation in HCT RecipientsSecondary· 36 weeks after the second dose of sotrovimab
Assessment of rates of new-onset allograft or stem cell failure requiring retransplantation in HCT recipients exposed to sotrovimab.
Group
Value
95% CI
Sotrovimab
0
Adverse events — posted to ClinicalTrials.gov
Time frame: 68-74 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is an open-label study examining the safety and tolerability of sotrovimab, administered in two sequential doses as prophylaxis in immunocompromised patients with impaired humoral immunity against SARS-CoV-2.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05305651 — Study to Monitor the Occurrence of Viral Variants in Patients With Compromised Immune Systems Being Treated for COVID-19
· Phase 4
· completed
NCT05398718 — Study on Sotrovimab and Its Impact on the Immune Response to COVID-19 Infection in Real-life in the UAE and Bahrain
· unknown
NCT05321394 — Non-inferiority Trial on Treatments in Early COVID-19
· Phase 3
· completed
NCT05135650 — Pharmacokinetics of Sotrovimab as Pre-exposure Prophylaxis for COVID-19 in Hematopoietic Stem Cell Transplant Recipients
· Phase 1
· terminated
NCT05124210 — Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild t
· Phase 2
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sophia Koo, M.D.
Last refreshed: 15 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05210101.