Severe COVID-19 DiseasePhase 2PC-COVID-HCMNCT04542967
Study on the Safety and Efficacy of Convalescent Plasma in Patients With Severe COVID-19 Disease
A Phase 2 study testing Biological in people with Severe COVID-19 Disease, run by Hospital Central Militar at 1 site in Mexico.
Trial summary
Currently, there is no specific treatment or vaccine for SARS-CoV-2 available, some drugs are being investigated as treatment, but the effect is unknown. A strategy and other method used before, in coronavirus pandemic (SARS-CoV in 2003 and MERS-CoV in 2012), was the use of immune (convalescent) plasma. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Severe COVID-19 Disease
- What is being tested?
- Biological
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteMexico
- Study dates
- 23 Jun 2020to 30 Sep 2020
- Phase
- Phase 2
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- O2 saturation <93%
- Radiographic evidence of moderate pneumonia according to Rale's classification.
- Acute respiratory distress syndrome (PaO2 / FiO2 <300 or SpO2 / FiO2 ≤ 315)
- Authorization to participate in the study and have informed consent letter, signed by the patient or the person responsible for the patient in case of critical patients (intubated)
Who cannot join
- Pregnant patients
- History of transfusion reactions
- Patients with congestive heart failure
- Patients with a history of chronic kidney failure on dialysis
- Patients with multiple organ failure
- Patients who does not accept or agree with the treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Convalescent Plasma as a Treatment for Patients With Severe COVID-19 Disease
Currently, there is no specific treatment or vaccine for SARS-CoV-2 available, some drugs are being investigated as treatment, but the effect is unknown. A strategy and other method used before, in coronavirus pandemic (SARS-CoV in 2003 and MERS-CoV in 2012), was the use of immune (convalescent) plasma. Passive administration of antibodies through convalescent plasma transfusion may offer the only short-term strategy available to confer immediate immunity and being a relative immediately resource available for treat COVID-19 disease. This research proposes the passive administration of antibodies through the transfusion of convalescent plasma, in patients with severe COVID-19 disease.
Read the detailed description
A randomized clinical trial comparing administration convalescent plasma to standard therapy for severe COVID-19 disease. Patients will be randomized 1:1 in a single blind study. The patients with SARS-CoV-2 PCR confirmed infection with pulmonary infiltrates and hypoxemia will be screened and invited to participate. Our primary outcomes will be disease progression and mortality, evaluate of ordinal Scale for Clinical Improvement and. (WHO)
- Conditions
- Severe COVID-19 Disease
- Being tested
- Biological
- Keywords
- SARS-CoV2, Convalescent Plasma, Severe Acute Respiratory Syndrome
- Medical subject headings
- Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiologicalBiological
Also called Convalescent plasma
An administration unit of 200 ml convalescent plasma intravenous infusion every 24 hours for two doses.
If a third dose of convalescent plasma is necessary, it may be used, as long as an evaluation of the research team is carried out.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | They will receive the standard care for critically ill inpatients. |
| Convalescent plasma group. | Experimental | They will receive standard care for patients with severe COVID-19 disease and convalescent plasma disease. Receives: Biological: Biological |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease progression
Change in ordinal Scale for Clinical Improvement (WHO). The progression disease, its the change in the severity score; a bigger number to the obtained after randomization
Measured: Up to 30 days later from study entry
Side effects
Side effects associated with the administration of convalescent plasma
Measured: Up to 30 days later from study entry
Mortality
Any cause of death
Measured: Up to 30 days later from study entry
Secondary outcomes (3)
Respiratory improvement
Change in partial pressure of arterial Oxygen to Fraction of inspired Oxygen ratio (PaO2/FiO2)
Measured: 10 days
Clinical improvement
Change in oxygen saturation levels
Measured: 10 days
Acute adverse events (AAE)
Transfusion reactions during transfusion.
Measured: After receiving intervention, an average time one hour, until 24 hours after administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start23 Jun 2020
- Primary completion2 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe COVID-19 DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The PC-COVID-HCM clinical trial is a randomized, controlled, single-blind study .
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Central Militar
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Carmen G Torres, MD, Principal investigator, Hospital Central Militar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542967
- Sponsor's protocol ID
- 047/2020
- Acronym
- PC-COVID-HCM
- Status last verified
- Sep 2020
- First submitted
- 4 Sep 2020
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to make IPD still not decided and would need approval by regulatory authorities
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convalescent Plasma as a Treatment for Patients With Severe COVID-19 Disease
- ClinicalTrials.gov ID
- NCT04542967
- Acronym / sponsor ID
- PC-COVID-HCM / 047/2020
- Conditions
- Severe COVID-19 Disease
- Keywords
- SARS-CoV2, Convalescent Plasma, Severe Acute Respiratory Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hospital Central MilitarOther government
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 2 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 9 Sep 2020 (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.
Currently, there is no specific treatment or vaccine for SARS-CoV-2 available, some drugs are being investigated as treatment, but the effect is unknown. A strategy and other method used before, in coronavirus pandemic (SARS-CoV in 2003 and MERS-CoV in 2012), was the use of immune (convalescent) plasma. Passive administration of antibodies through convalescent plasma transfusion may offer the only short-term strategy available to confer immediate immunity and being a relative immediately resource available for treat COVID-19 disease. This research proposes the passive administration of antibodies through the transfusion of convalescent plasma, in patients with severe COVID-19 disease.
Detailed description
A randomized clinical trial comparing administration convalescent plasma to standard therapy for severe COVID-19 disease. Patients will be randomized 1:1 in a single blind study. The patients with SARS-CoV-2 PCR confirmed infection with pulmonary infiltrates and hypoxemia will be screened and invited to participate. Our primary outcomes will be disease progression and mortality, evaluate of ordinal Scale for Clinical Improvement and. (WHO)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The PC-COVID-HCM clinical trial is a randomized, controlled, single-blind study .
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –They will receive the standard care for critically ill inpatients. |
| Convalescent plasma group. | Experimental | Biological: BiologicalThey will receive standard care for patients with severe COVID-19 disease and convalescent plasma disease. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- O2 saturation <93%
- Radiographic evidence of moderate pneumonia according to Rale's classification.
- Acute respiratory distress syndrome (PaO2 / FiO2 <300 or SpO2 / FiO2 ≤ 315)
- Authorization to participate in the study and have informed consent letter, signed by the patient or the person responsible for the patient in case of critical patients (intubated)
Key exclusion criteria (6 listed)
- Pregnant patients
- History of transfusion reactions
- Patients with congestive heart failure
- Patients with a history of chronic kidney failure on dialysis
- Patients with multiple organ failure
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 |
|---|---|---|
| BiologicalAlso: Convalescent plasmaAn administration unit of 200 ml convalescent plasma intravenous infusion every 24 hours for two doses. If a third dose of convalescent plasma is necessary, it may be used, as long as an evaluation of the research team is carried out. | Biological | Convalescent plasma group. |
Primary outcome
Disease progression
Time frame: Up to 30 days later from study entry
Change in ordinal Scale for Clinical Improvement (WHO). The progression disease, its the change in the severity score; a bigger number to the obtained after randomization
Side effects
Time frame: Up to 30 days later from study entry
Side effects associated with the administration of convalescent plasma
Mortality
Time frame: Up to 30 days later from study entry
Any cause of death
3 secondary outcomes
Respiratory improvement
Time frame: 10 days
Clinical improvement
Time frame: 10 days
Acute adverse events (AAE)
Time frame: After receiving intervention, an average time one hour, until 24 hours after administration.
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 10 May 2021.
- Clinical Characteristics of Coronavirus Disease 2019 in ChinaLink provided by the sponsor.
- Potential interventions for novel coronavirus in China: A systematic reviewLink provided by the sponsor.
- Use of convalescent plasma therapy in SARS patients in Hong KongLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Plan to make IPD still not decided and would need approval by regulatory authorities
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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.
Carmen G Torres, MD principal investigator
Hospital Central Militar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biological in people with Severe COVID-19 Disease, run by Hospital Central Militar at 1 site in Mexico.
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 6 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 10 May 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 Mexico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Disease progression (time frame: Up to 30 days later from study entry). The study lists 3 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 10 May 2021.