COVID-19NCT05398718
Study on Sotrovimab and Its Impact on the Immune Response to COVID-19 Infection in Real-life in the UAE and Bahrain
An observational study of COVID-19, run by Abu Dhabi Health Services Company at 1 site in Bahrain.
Trial summary
The United Arab Emirates (UAE), the Kingdom of Bahrain, Kuwait, Oman, and Qatar have authorised sotrovimab for emergency use. Local experience among physicians include recent successful COVID-19 vaccine pivotal studies supported by the authorities' willingness to expedite understanding of the role of monoclonal… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Sotrovimab
- How many people
- 20,000 participants
- Where
- 1 siteBahrain
- Study dates
- 12 May 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with mild-to-moderate COVID-19 as confirmed by approved local laboratory tests
Who may be able to join
- Adults and paediatric patients (≥ 12 years of age weighing at least 40 kg)
- Mild-to-moderate COVID-19
- Positive results of direct SARS-CoV-2 viral testing
- High risk for progression to severe COVID-19
Who cannot join
- Patients who are hospitalised due to COVID-19 before sotrovimab administration
- Patients who require oxygen therapy due to COVID-19 before sotrovimab administration oPatients who received pharmacological treatment including monoclonal antibodies to any components of SARS-CoV-2 virus within 6 months prior to enrolment into the study in retrospective and prospective arms.
Trial locations and contacts
1 site in 1 country.
Bahrain1 site, 1 recruiting
- Recruiting
The National Taskforce for combating COVID-19, Royal Medical Services.
Manama
Manaf Al Qahtani, MD
About this study
Official title: Bi-directional Real-world Cohort Study on Sotrovimab and Its Impact on the Strength and Duration of the Immune Response to Natural SARS-CoV-2 Infection in Real-life Setting in the UAE and the Kingdom of Bahrain
The United Arab Emirates (UAE), the Kingdom of Bahrain, Kuwait, Oman, and Qatar have authorised sotrovimab for emergency use. Local experience among physicians include recent successful COVID-19 vaccine pivotal studies supported by the authorities' willingness to expedite understanding of the role of monoclonal antibodies such as sotrovimab in the management of COVID-19 and expertise to integrate the latest knowledge into the local or regional COVID-19 management guidelines. The aim of this study is to collect local clinical evidence for sotrovimab effect in the real-life setting in the UAE and the Kingdom of Bahrain. Overall study population is 20,000 and the duration of the study will be approximately six months from recruitment date.
- Conditions
- COVID-19
- Being tested
- Sotrovimab
- Keywords
- Sotrovimab
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotrovimabDrug
collect local clinical evidence for sotrovimab effect in the real-life setting
| Study group | Role | What they receive |
|---|---|---|
| Sotrovimab Arm | Not described Receives: Drug: Sotrovimab | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Proportion of patients with COVID-19 progression through Day 29 after sotrovimab administration:
- Proportion of patients with COVID-19 progression through Day 29 after sotrovimab administration:
- Requiring supplemental oxygen
- Requiring ICU and/or general ward admission
- Death
- Time to first PCR negative status after the COVID-19 symptom onset
- Time to first PCR negative status after date of sotrovimab administration
Measured: 6 months
To assess the impact of sotrovimab on the strength and duration of the immune response to natural SARS-CoV-2 infection in real-life setting in the UAE and Bahrain.
Defined as
- Change from baseline in mean levels of elevated SARS-CoV-2 functional neutralising antibodies at Day 29, Day 60 and Day 180 after sotrovimab administration, these will be presented as proportion of patients with that response
Measured: 6 months
Secondary outcomes (4)
To evaluate the impact of sotrovimab on the duration and the severity of COVID-19 clinical symptoms
Time to key clinical symptoms alleviation from symptom onset and sotrovimab administration at baseline, Day 29 after sotrovimab administration and Day of symptoms free (for all 350 patients in the interventional phase and part of the patients in the observational phase). Key clinical symptoms alleviation is defined as the clinical resolution of shortness of breath, fever, and body ache
Measured: 6 months
To evaluate the impact of sotrovimab in reducing SARS-CoV-2 viral load and in preventing COVID-19 respiratory disease progression.
Measured: 6 months
To assess the safety of sotrovimab in real-life setting in the UAE and Bahrain
Defined as:
- Occurrence of adverse events (AEs) and serious adverse events (SAEs) through Day 29 after sotrovimab administration
- . Proportion of patients with AEs and SAEs through Day 29 after sotrovimab administration.
Measured: 6 months
To assess the impact of sotrovimab on the strength and duration of the immune response to natural SARS-CoV-2 infection in real-life setting in the UAE and Bahrain.
Defined as:
- Change from baseline in mean levels of elevated SARS-CoV-2 functional neutralising antibodies at Day 29, Day 60 and Day 180 after sotrovimab administration in patients, who received their complete or incomplete vaccination course within 3 months prior to COVID-19 symptom onset, these will be presented as proportion of patients with that response.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start12 May 2022
- Primary completion15 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abu Dhabi Health Services Company
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398718
- Sponsor's protocol ID
- Abu Dhabi Health Services
- Status last verified
- May 2022
- First submitted
- 29 Apr 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bi-directional Real-world Cohort Study on Sotrovimab and Its Impact on the Strength and Duration of the Immune Response to Natural SARS-CoV-2 Infection in Real-life Setting in the UAE and the Kingdom of Bahrain
- ClinicalTrials.gov ID
- NCT05398718
- Acronym / sponsor ID
- Abu Dhabi Health Services
- Conditions
- COVID-19
- Keywords
- Sotrovimab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Abu Dhabi Health Services CompanyOther government
- Study start
- 12 May 2022 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The United Arab Emirates (UAE), the Kingdom of Bahrain, Kuwait, Oman, and Qatar have authorised sotrovimab for emergency use. Local experience among physicians include recent successful COVID-19 vaccine pivotal studies supported by the authorities' willingness to expedite understanding of the role of monoclonal antibodies such as sotrovimab in the management of COVID-19 and expertise to integrate the latest knowledge into the local or regional COVID-19 management guidelines. The aim of this study is to collect local clinical evidence for sotrovimab effect in the real-life setting in the UAE and the Kingdom of Bahrain. Overall study population is 20,000 and the duration of the study will be approximately six months from recruitment date.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sotrovimab Arm | – | Drug: Sotrovimab |
| Control | – | – |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with mild-to-moderate COVID-19 as confirmed by approved local laboratory tests
Key inclusion criteria (4 listed)
- Adults and paediatric patients (≥ 12 years of age weighing at least 40 kg)
- Mild-to-moderate COVID-19
- Positive results of direct SARS-CoV-2 viral testing
- High risk for progression to severe COVID-19
Key exclusion criteria (2 listed)
- Patients who are hospitalised due to COVID-19 before sotrovimab administration
- Patients who require oxygen therapy due to COVID-19 before sotrovimab administration oPatients who received pharmacological treatment including monoclonal antibodies to any components of SARS-CoV-2 virus within 6 months prior to enrolment into the study in retrospective and prospective arms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sotrovimabcollect local clinical evidence for sotrovimab effect in the real-life setting | Drug | Sotrovimab Arm |
Primary outcome
• Proportion of patients with COVID-19 progression through Day 29 after sotrovimab administration:
Time frame: 6 months
* Proportion of patients with COVID-19 progression through Day 29 after sotrovimab administration: * Requiring supplemental oxygen * Requiring ICU and/or general ward admission * Death * Time to first PCR negative status after the COVID-19 symptom onset * Time to first PCR negative status after date of sotrovimab administration
To assess the impact of sotrovimab on the strength and duration of the immune response to natural SARS-CoV-2 infection in real-life setting in the UAE and Bahrain.
Time frame: 6 months
Defined as • Change from baseline in mean levels of elevated SARS-CoV-2 functional neutralising antibodies at Day 29, Day 60 and Day 180 after sotrovimab administration, these will be presented as proportion of patients with that response
4 secondary outcomes
To evaluate the impact of sotrovimab on the duration and the severity of COVID-19 clinical symptoms
Time frame: 6 months
To evaluate the impact of sotrovimab in reducing SARS-CoV-2 viral load and in preventing COVID-19 respiratory disease progression.
Time frame: 6 months
To assess the safety of sotrovimab in real-life setting in the UAE and Bahrain
Time frame: 6 months
To assess the impact of sotrovimab on the strength and duration of the immune response to natural SARS-CoV-2 infection in real-life setting in the UAE and Bahrain.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Abu Dhabi Health Services Company at 1 site in Bahrain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bahrain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nawal Al Kaabi, MD (+97124102985, research@seha.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Proportion of patients with COVID-19 progression through Day 29 after sotrovimab administration: (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.