Convalescent PlasmaPhase 3NCT04816942
Clinical Efficacy of Early Administration of Convalescent Plasma Among COVID-19 Cases in Egypt
A Phase 3 study testing Convalescent Plasma in people with Convalescent Plasma and Covid19, run by Ministry of Health and Population, Egypt at 1 site in Egypt.
Trial summary
One investigational treatment being explored for COVID-19 is the use of convalescent plasma collected from individuals who have recovered from COVID-19 (Refs. 1-4). Convalescent plasma that contains antibodies to severe acute respiratory syndrome coronavirus 2 or SARSCoV-2 (the virus that causes COVID-19) is being… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Convalescent Plasma, Covid19, Immunoglobulins
- What is being tested?
- Convalescent Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Apr 2020to 12 Oct 2020
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laboratory confirmed COVID-19. Severe or immediately life-threatening COVID-19,
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
One investigational treatment being explored for COVID-19 is the use of convalescent plasma collected from individuals who have recovered from COVID-19 (Refs. 1-4). Convalescent plasma that contains antibodies to severe acute respiratory syndrome coronavirus 2 or SARSCoV-2 (the virus that causes COVID-19) is being studied for administration to patients with COVID-19. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic (Refs. 5-7).
Although promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19. Therefore, it is important to study the safety and efficacy of COVID19 convalescent plasma in clinical trials. This guidance provides recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency. This guidance also provides recommendations to blood establishments on the collection of COVID-19 convalescent plasma..
Read the detailed description
laboratory-confirmed patients using qRT-PCR will be enrolled in the study. Eligibility criteria for recipients are ; laboratory-confirmed SARS-CoV-2, Severe or immediately life-threatening. Severe disease defined as one or more of the following; shortness of breath( dyspnoea), respiratory frequency≥ 30/min, blood oxygen saturation ≤93%, a partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300, and lung infiltrates >50% within 24-48 hours. While a life-threatening disease is defined as one or more of the following; respiratory failure, need for mechanical ventilation, septic shock and multiple organ dysfunction or failure.
Intervention: All patients included in the study provided will be administered with two plasma units (each unit is 200cc).
Primary measure is the degree of clinical improvement among the COVID-19 patients who receive CPT within seven days as compared with the patients who receive after seven days. Case Fatality will be assessed among the enrolled cases
- Conditions
- Convalescent Plasma, Covid19, Immunoglobulins, Plasma, Egypt
- Being tested
- Convalescent Plasma
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convalescent PlasmaBiological
Two units of ABO compatible COVID-19 convalescent plasma will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Convalescent Plasma | Experimental | Patients receiving Two units of ABO compatible COVID-19 convalescent plasma will be administered.P Receives: Biological: Convalescent Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 Cure rate
Primary measure was the degree of clinical improvement among the COVID-19 patients who received CPT within seven days as compared with the patients who received after seven days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start23 Apr 2020
- Primary completion21 Jul 2020
- Study completion12 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Convalescent PlasmaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health and Population, Egypt
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816942
- Sponsor's protocol ID
- 10-2020/13
- Status last verified
- Mar 2021
- First submitted
- 12 Feb 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Early Administration of Convalescent Plasma Among COVID-19 Cases in Egypt
- ClinicalTrials.gov ID
- NCT04816942
- Acronym / sponsor ID
- 10-2020/13
- Conditions
- Convalescent Plasma, Covid19, Immunoglobulins, Plasma, Egypt
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ministry of Health and Population, EgyptOther government
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 12 Oct 2020 (actual)
- First posted
- 25 Mar 2021 (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.
One investigational treatment being explored for COVID-19 is the use of convalescent plasma collected from individuals who have recovered from COVID-19 (Refs. 1-4). Convalescent plasma that contains antibodies to severe acute respiratory syndrome coronavirus 2 or SARSCoV-2 (the virus that causes COVID-19) is being studied for administration to patients with COVID-19. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic (Refs. 5-7).
Although promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19. Therefore, it is important to study the safety and efficacy of COVID19 convalescent plasma in clinical trials. This guidance provides recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency. This guidance also provides recommendations to blood establishments on the collection of COVID-19 convalescent plasma..
Detailed description
laboratory-confirmed patients using qRT-PCR will be enrolled in the study. Eligibility criteria for recipients are ; laboratory-confirmed SARS-CoV-2, Severe or immediately life-threatening. Severe disease defined as one or more of the following; shortness of breath( dyspnoea), respiratory frequency≥ 30/min, blood oxygen saturation ≤93%, a partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300, and lung infiltrates >50% within 24-48 hours. While a life-threatening disease is defined as one or more of the following; respiratory failure, need for mechanical ventilation, septic shock and multiple organ dysfunction or failure.
Intervention: All patients included in the study provided will be administered with two plasma units (each unit is 200cc).
Primary measure is the degree of clinical improvement among the COVID-19 patients who receive CPT within seven days as compared with the patients who receive after seven days. Case Fatality will be assessed among the enrolled cases
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Convalescent Plasma | Experimental | Biological: Convalescent PlasmaPatients receiving Two units of ABO compatible COVID-19 convalescent plasma will be administered.P |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Laboratory confirmed COVID-19. Severe or immediately life-threatening COVID-19,
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Convalescent PlasmaTwo units of ABO compatible COVID-19 convalescent plasma will be administered. | Biological | Convalescent Plasma |
Primary outcome
COVID-19 Cure rate
Time frame: 30 days
Primary measure was the degree of clinical improvement among the COVID-19 patients who received CPT within seven days as compared with the patients who received after seven days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Convalescent Plasma in people with Convalescent Plasma and Covid19, run by Ministry of Health and Population, Egypt at 1 site in Egypt.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 25 Mar 2021. 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 Cure rate (time frame: 30 days). 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 25 Mar 2021.