CoronavirusNCT04292340
Anti-SARS-CoV-2 Inactivated Convalescent Plasma in the Treatment of COVID-19
An observational study of Coronavirus, run by Shanghai Public Health Clinical Center at 1 site in China.
Trial summary
There is still no effective antiviral drugs and vaccines against SARS-CoV-2 yet now. This is an obsevational study, the investigators collected the clinical information and clinical outcomes of the COVID-19 patients using anti-2019-nCoV inactivated convalescent plasma.The study is to evaluate the efficacy and safety… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronavirus
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 31 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants received anti-SARS-CoV-2 inactivated convalescent plasma
Who may be able to join
- The participants were diagnosed as COVID-19;
- Participants received anti-SARS-CoV-2 inactivated convalescent plasma
- Written the informed consent.
Who cannot join
- Participants lacked detailed medical history
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508
Jun Chen, 008602137990333 ext. 3222
About this study
Official title: The Efficacy and Safety of Anti-SARS-CoV-2 Inactivated Convalescent Plasma in the Treatment of Novel Coronavirus Pneumonia Patient (COVID-19) : An Observational Study
There is still no effective antiviral drugs and vaccines against SARS-CoV-2 yet now. This is an obsevational study, the investigators collected the clinical information and clinical outcomes of the COVID-19 patients using anti-2019-nCoV inactivated convalescent plasma.The study is to evaluate the efficacy and safety of anti-2019-nCoV inactivated convalescent plasma in the treatment of COVID-19 pneumonia.
- Conditions
- Coronavirus
- Keywords
- Plasma transfusion, Coronavirus
- Medical subject headings
- Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 1
The SARS-CoV-2 nuclei acid was quantified using RT-PCR
Measured: 1 day after receiving plasma transmission
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3
Measured: 3 days after receiving plasma transmission
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7
Measured: 7 days after receiving plasma transmission
Numbers of participants with different Clinical outcomes
Clinical outcomes include death, critical illness, recovery
Measured: From receiving plasma transmission to 4 weeks
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 4 weeks after receiving plasma transmission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Feb 2020
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hongzhou Lu, Shanghai Public Health Clinical Center
- Investigators
- Hongzhou Lu, Ph.D, Principal investigator, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292340
- Sponsor's protocol ID
- Anti-SARS-CoV-2
- Status last verified
- Feb 2020
- First submitted
- 25 Feb 2020
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Anti-SARS-CoV-2 Inactivated Convalescent Plasma in the Treatment of Novel Coronavirus Pneumonia Patient (COVID-19) : An Observational Study
- ClinicalTrials.gov ID
- NCT04292340
- Acronym / sponsor ID
- Anti-SARS-CoV-2
- Conditions
- Coronavirus
- Keywords
- Plasma transfusion, Coronavirus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shanghai Public Health Clinical CenterOther government
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 3 Mar 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.
There is still no effective antiviral drugs and vaccines against SARS-CoV-2 yet now. This is an obsevational study, the investigators collected the clinical information and clinical outcomes of the COVID-19 patients using anti-2019-nCoV inactivated convalescent plasma.The study is to evaluate the efficacy and safety of anti-2019-nCoV inactivated convalescent plasma in the treatment of COVID-19 pneumonia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants received anti-SARS-CoV-2 inactivated convalescent plasma
Key inclusion criteria (3 listed)
- The participants were diagnosed as COVID-19;
- Participants received anti-SARS-CoV-2 inactivated convalescent plasma
- Written the informed consent.
Key exclusion criteria (1 listed)
- Participants lacked detailed medical history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 1
Time frame: 1 day after receiving plasma transmission
The SARS-CoV-2 nuclei acid was quantified using RT-PCR
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3
Time frame: 3 days after receiving plasma transmission
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7
Time frame: 7 days after receiving plasma transmission
Numbers of participants with different Clinical outcomes
Time frame: From receiving plasma transmission to 4 weeks
Clinical outcomes include death, critical illness, recovery
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 4 weeks after receiving plasma transmission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
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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.
Hongzhou Lu, Ph.D principal investigator
Shanghai Public Health Clinical Center
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 Coronavirus, run by Shanghai Public Health Clinical Center at 1 site in China.
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 3 inclusion and 1 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 3 Mar 2020. 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 China. 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 Hongzhou Lu, Ph.D (+86-021-37990333 ext. 3222, luhongzhou@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 1 (time frame: 1 day after receiving plasma transmission). The study lists 4 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 3 Mar 2020.