COVID-19
Conditions
Keywords
Mild to Moderate COVID-19
Brief 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.
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.
Interventions
None listed
Sponsors
ShuGuang Hospital
Shanghai Pudong Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to sustained clinical recovery | Up to 28 days | Time to sustained clinical recovery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who experience these events | Day 1 to 28 days | Percentage of participants who experience these events: Progress to severe and/or critical COVID-19; Death from any cause |
| Time to sustained disappearance of clinical symptoms | Up to 28 days | Time to sustained disappearance of clinical symptoms |
| Percentage of clinical recovery participants | Day 3, 5, 7, 10, 14, 21 and 28 | Percentage of clinical recovery participants from baseline to Day 3, 5, 7, 10, 14, 21 and 28 |
| Percentage of participants with no clinical symptoms | Day 3, 5, 7, 10, 14, 21 and 28 | Percentage of participants with no clinical symptoms from baseline to Day 3, 5, 7, 10, 14, 21 and 28 |
| Percentage of the participants who have progression of COVID-19 | Day 1 to 28 days | Percentage of participants who experience these events: Progress to severe and/or critical COVID-19; Death from any cause |
| Percentage of participants who turned negative for SARS-CoV-2 | Day 3, 5, 7, 10, 14 | Percentage of participants who turned negative for SARS-COV-2 at Day 3, 5, 7, 10, 14 |
| The change of SARS-COV-2 Ct value | Day 3, 5, 7, 10, 14 | The change of SARS-COV-2 Ct value The change of SARS-COV-2 Ct value at Day 3, 5, 7, 10, 14 |
| Safety assessment Results: such as AEs and SAEs through Day 28 | Up to 28 days | Safety assessment Results: such as AEs and SAEs through Day 28 |
| The change of COVID-19 symptom scores | Day 3, 5, 7, 10, 14, 21 and 28 | 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. |
Countries
China
Contacts
Primary ContactMinghua Yu
Outcome results
None listed