COVID-19NCT05366244
An Observational Study in Patients With Mild to Moderate COVID-19
An observational study of COVID-19, run by Shanghai Pudong Hospital at 2 sites in China.
Trial summary
The purpose of this study was to observe real-world disease progression in mild-moderate COVID-19 patients with at least one risk factor for serve COVID-19 illness or death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 2 May 2022to 30 Apr 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mild to Moderate COVID-19
Who may be able to join
- Participants who have a positive SARS-CoV-2 test result.
- Participants who have one or more mild or moderate COVID-19 symptoms.
- Participants who have one or more of the following requirements: ≤7 days from the first positive test for SARS-COV-2 virus infection to Day 1; ≤5 days from the first onset of COVID-19 symptoms to Day 1.
- Participants who satisfy one or more than one of the following high risks for progression to severe COVID-19, including death.
- Participants who understand and agree to comply with planned study procedures.
- Participants or legally authorized representatives can give written informed consent approved by the Ethical Review Board governing the site.
- Capable of giving signed informed consent, including of compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- Participants who are judged by the investigator as likely to progress to severe/critical COVID-19 prior to randomization.
- Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300, or respiratory rate ≥30 per minute.
- Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation.
- Participants who have received or plan to receive a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment).
- Participants who have received convalescent COVID-19 plasma treatment.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Shuguang Hospital
Shanghai, Shanghai Municipality, 201203
Yueqiu Gao
- Recruiting
Shanghai Pudong Hospital
Shanghai, Shanghai Municipality, 201399
Minghua Yu
About this study
Official title: An Observational, Real World Study to Observe Disease Outcomes in Patients With Mild to Moderate Coronavirus Disease 2019 (COVID-19)
The purpose of this study was to observe real-world disease progression in mild-moderate COVID-19 patients with at least one risk factor for serve COVID-19 illness or death.
Read the detailed description
Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures.
The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.
The following is the general sequence of events during the 28-day evaluation period:
Completion of baseline procedures Participants were assessed for 28 days and completed all safety monitoring.
- Conditions
- COVID-19
- Keywords
- Mild to Moderate COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient with COVID-19 | Mild to moderate COVID-19 patient with at least one risk factor for serve COVID-19 illness or death. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to sustained clinical recovery
Time to sustained clinical recovery
Measured: Up to 28 days
Secondary outcomes (9)
Percentage of the participants who have progression of COVID-19
Percentage of participants who experience these events: Progress to severe and/or critical COVID-19; Death from any cause
Measured: Day 1 to 28 days
Percentage of participants who experience these events
Percentage of participants who experience these events: Progress to severe and/or critical COVID-19; Death from any cause
Measured: Day 1 to 28 days
Time to sustained disappearance of clinical symptoms
Time to sustained disappearance of clinical symptoms
Measured: Up to 28 days
Percentage of clinical recovery participants
Percentage of clinical recovery participants from baseline to Day 3, 5, 7, 10, 14, 21 and 28
Measured: Day 3, 5, 7, 10, 14, 21 and 28
Percentage of participants with no clinical symptoms
Percentage of participants with no clinical symptoms from baseline to Day 3, 5, 7, 10, 14, 21 and 28
Measured: Day 3, 5, 7, 10, 14, 21 and 28
The change of COVID-19 symptom scores
The change of "COVID-19 symptom scores" from baseline to Day 3, 5, 7, 10, 14, 21 and 28, the score ranges from 0 to 33 and higher scores mean a worse symptom.
Measured: Day 3, 5, 7, 10, 14, 21 and 28
Percentage of participants who turned negative for SARS-CoV-2
Percentage of participants who turned negative for SARS-COV-2 at Day 3, 5, 7, 10, 14
Measured: Day 3, 5, 7, 10, 14
The change of SARS-COV-2 Ct value
The change of SARS-COV-2 Ct value The change of SARS-COV-2 Ct value at Day 3, 5, 7, 10, 14
Measured: Day 3, 5, 7, 10, 14
Safety assessment Results: such as AEs and SAEs through Day 28
Safety assessment Results: such as AEs and SAEs through Day 28
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start2 May 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pudong Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ShuGuang Hospital
- Responsible party
- Sponsor
- Investigators
- Minghua Yu, Principal investigator, Shanghai Pudong HospitalYueqiu Gao, Principal investigator, ShuGuang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366244
- Sponsor's protocol ID
- JT001-010x-COVID-19
- Status last verified
- May 2022
- First submitted
- 6 May 2022
- Last updated
- 19 May 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 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Real World Study to Observe Disease Outcomes in Patients With Mild to Moderate Coronavirus Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT05366244
- Acronym / sponsor ID
- JT001-010x-COVID-19
- Conditions
- COVID-19
- Keywords
- Mild to Moderate COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Pudong HospitalUniversity, hospital or other
- Collaborators
- ShuGuang Hospital
- Study start
- 2 May 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 9 May 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 purpose of this study was to observe real-world disease progression in mild-moderate COVID-19 patients with at least one risk factor for serve COVID-19 illness or death.
Detailed description
Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures.
The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.
The following is the general sequence of events during the 28-day evaluation period:
Completion of baseline procedures Participants were assessed for 28 days and completed all safety monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with COVID-19 | – | –Mild to moderate COVID-19 patient with at least one risk factor for serve COVID-19 illness or death. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mild to Moderate COVID-19
Key inclusion criteria (7 listed)
- Participants who have a positive SARS-CoV-2 test result.
- Participants who have one or more mild or moderate COVID-19 symptoms.
- Participants who have one or more of the following requirements: ≤7 days from the first positive test for SARS-COV-2 virus infection to Day 1; ≤5 days from the first onset of COVID-19 symptoms to Day 1.
- Participants who satisfy one or more than one of the following high risks for progression to severe COVID-19, including death.
- Participants who understand and agree to comply with planned study procedures.
Key exclusion criteria (5 listed)
- Participants who are judged by the investigator as likely to progress to severe/critical COVID-19 prior to randomization.
- Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300, or respiratory rate ≥30 per minute.
- Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation.
- Participants who have received or plan to receive a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment).
- Participants who have received convalescent COVID-19 plasma treatment.
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
Time to sustained clinical recovery
Time frame: Up to 28 days
Time to sustained clinical recovery
9 secondary outcomes
Percentage of the participants who have progression of COVID-19
Time frame: Day 1 to 28 days
Percentage of participants who experience these events
Time frame: Day 1 to 28 days
Time to sustained disappearance of clinical symptoms
Time frame: Up to 28 days
Percentage of clinical recovery participants
Time frame: Day 3, 5, 7, 10, 14, 21 and 28
Percentage of participants with no clinical symptoms
Time frame: Day 3, 5, 7, 10, 14, 21 and 28
The change of COVID-19 symptom scores
Time frame: Day 3, 5, 7, 10, 14, 21 and 28
Percentage of participants who turned negative for SARS-CoV-2
Time frame: Day 3, 5, 7, 10, 14
The change of SARS-COV-2 Ct value
Time frame: Day 3, 5, 7, 10, 14
Safety assessment Results: such as AEs and SAEs through Day 28
Time frame: Up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 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.
Minghua Yu principal investigator
Shanghai Pudong Hospital
Yueqiu Gao principal investigator
ShuGuang Hospital
2 sites 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 Shanghai Pudong Hospital at 2 sites 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 7 inclusion and 5 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 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Minghua Yu (+86-18017821601, minghua_md@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to sustained clinical recovery (time frame: Up to 28 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 19 May 2022.