PET/CTNCT04519255
Study for Quantitative Analysis of the Recovered COVID-19 Patients by 18F-FDG-PET/CT
An observational study of PET/CT and COVID-19, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
In this study, clinically cured patients with severe COVID-19 were used to evaluate the therapeutic effect of COVID-19 and the recovery and health status of patients over time with highly sensitive PET/CT imaging technology. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- PET/CT, COVID-19, Respiratory Function
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 31 Jul 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with COVID-19 cured were determined based on nucleic acid tests, CT examinations, and clinical criteria. The age of patient were between 18 and 85 years, meanwhile in Zhuhai they were confirmed as COVID-19, cured and all received by COVID-19 drug therapy.
Who may be able to join
- Screening of clinically cured patients with severe COVID-19:
- Patients with severe COVID-19 cure were determined based on nucleic acid tests, CT examinations, and clinical criteria;
- Age > 18 years, age < 85 years, no gender restriction;
- All had received COVID-19 drug therapy;
- ECOG of general condition score: 0-2; No dysfunction of main viscera; Oxygen partial pressure ≥10.64kPa; White blood cells ≥4×109/L; Blood routine hemoglobin ≥9.5g/dL; The absolute count of neutrophils ≥1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤1.5 times the upper limit of normal value; Creatinine ≤1.25 times the upper limit of normal value; The creatinine clearance rate was ≥60ml/min;
- Can obtain complete follow-up information, understand the situation of this study and sign informed consent.
Show all 12Show fewer
- Screening of clinically cured patients with mild COVID-19:
- Patients with mild COVID-19 cure were determined based on nucleic acid tests, CT examinations, and clinical criteria;
- Age > 18 years, age < 85 years, no gender restriction;
- All had received COVID-19 drug therapy;
- ECOG of general condition score: 0-2; No dysfunction of main viscera; Oxygen partial pressure ≥10.64kPa; White blood cells ≥4×109/L; Blood routine hemoglobin ≥9.5g/dL; The absolute count of neutrophils ≥1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤1.5 times the upper limit of normal value; Creatinine ≤1.25 times the upper limit of normal value; The creatinine clearance rate was ≥60ml/min;
- Can obtain complete follow-up information, understand the situation of this study and sign informed consent.
Who cannot join
- Poorly controlled diabetics (fasting glucose level and GT;200 mg/dL);
- Any other malignancy within 5 years;
- Breastfeeding and/or pregnant women;
- Those who are prone to severe bleeding;
- Recent severe hemoptysis, severe cough, dyspnea or patients cannot cooperate;
- Severe emphysema, pulmonary congestion and pulmonary heart disease;
- The researchers believe that the subjects may not be able to complete the study or comply with the requirements of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Open, Prospective, Randomized Pilot Study for Quantitative Analysis of Whole Body Inflammatory Lesions in Recovered COVID-19 Patients by 18F-FDG-PET/CT
In this study, clinically cured patients with severe COVID-19 were used to evaluate the therapeutic effect of COVID-19 and the recovery and health status of patients over time with highly sensitive PET/CT imaging technology. At the same time, PET/CT whole body scan, dynamic imaging and mathematical dynamic model were combined to evaluate the functions of the heart, lung, liver, kidney, brain and other important organs and the outcome of inflammatory lesions in clinically cured COVID-19 patients.
Read the detailed description
Covid-19 (Corona Virus Disease 2019, COVID-19), referred to as "COVID-19", refers to the pneumonia caused by novel Coronavirus 2019 (2019-NCOV/SARS-COV-2) infection. The clinical manifestations of the new patients were fever, fatigue and dry cough, while the symptoms of upper respiratory tract such as nasal congestion and runny nose were rare. Hypoxia occurs. About half of the patients developed dyspnea after one week, and in severe cases, the rapid progression was acute respiratory distress syndrome, septic shock, metabolic acidosis that was difficult to correct, and coagulation dysfunction. After the outbreak of COVID-19 in China, the National Health Commission issued the Diagnosis and Treatment Plan for COVID-19. By analyzing the epidemic situation and research progress, it organized experts to timely revise the diagnosis and treatment plan based on the analysis, study and summary of the previous medical treatment work.The discharge criteria for COVID-19 patients notified by the National Health Commission are remission of clinical symptoms, normal body temperature, normal CT, and negative nucleic acid tests for both tests. So far, the COVID-19 epidemic in China has been well under control. According to the latest statistics, 84,311 cases have been confirmed in total, and 1,433 cases have been confirmed so far.But studies (the latest from Dena Goffman's team, published in the NEJM) suggest that as many as 88 percent of coVID-19 patients are asymptomatic. Do cured patients leave the hospital with a percentage of asymptomatic patients?In addition, covid-19 cured patients in some regions turned positive again after discharge, indicating that long-term follow-up monitoring is of great significance for cured and discharged patients in addition to routine isolation observation!Moreover the literature at home and abroad other viral infections (such as hepatitis b, HIV, etc.) to cure patients found that the virus may lurk for a long time, the virus quantity contained in a very low level, the conventional detection method is difficult to detect, at the appropriate incentives can lead to attack, so for the new crown cure patients need close monitoring of systemic inflammation related lesions, and the situation of the latent virus.However, we still face many problems and challenges. For example, according to the latest data published by Dena Goffman's team in NEJM, the proportion of asymptomatic patients is as high as 88%, so the screening of asymptomatic patients is crucial.In many places, COVID-19 patients cured turn positive again after discharge. Therefore, it is of great significance to explore the mechanism of COVID-19 turning negative after discharge and evaluate the effect of novel Coronavirus and COVID-19 on patients' later recovery. Explore and develop more efficient and sensitive clinical detection methods to evaluate the treatment effect of covid-19 patients.
Positron emission computed tomography imaging technique is a nuclear medicine clinical diagnosis of advanced imaging techniques, can be shown on the in vivo biological molecules (such as 18 F- FDG, tracer nuclide labeled glucose molecules) metabolism, receptors and neurotransmitter activity of new functional imaging techniques, has been widely used in many kinds of disease diagnosis and differential diagnosis, a judgment, curative effect evaluation, viscera function research and development of new drugs, etc. Compared with traditional anatomical structure imaging, functional imaging PET has the following advantages: (1) High sensitivity. According to the test, PET molecular probe can pick up molecular events at the level of PM-NM in vivo. (2) High specificity, for the PET selected molecular probe, can only imaging the target molecules, for the same family of receptors, because the binding degree difference can be specifically distinguished; (3) Whole-body imaging, that is, one time PET imaging can obtain images of all regions of the whole body, and through the analysis can obtain the dynamic information of the metabolic changes of human tissues over time, which is of great significance for the research, prevention and evaluation of diseases.In particular, PET/CT scan provides a more reliable means of systemic monitoring for viruses that are lurking in all hidden parts of the body. (4) Security is good, although there are some radioactive nuclide PET need, but the amount of nuclide rarely used with short half-life, through two aspects of physical decay and biological metabolism function, in a very short time, client retention, a PET general inspection of radiation dose is far less than the conventional CT examination of a part, and safe and reliable.
- Conditions
- PET/CT, COVID-19, Respiratory Function, Inflammatory Lesions
- Medical subject headings
- COVID-19, Respiratory Aspiration
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 |
|---|---|---|
| Screening of clinically cured patients with severe COVID-19 | ①Patients with severe COVID-19 cure were determined based on nucleic acid tests, CT examinations, and clinical criteria; ②Age > 18 years, age < 85 years, no gender restriction; ③ All had received COVID-19 drug therapy; ④ ECOG of general condition score: 0-2; No dysfunction of main viscera; Oxygen partial pressure ≥10.64kPa; White blood cells ≥4×109/L; Blood routine hemoglobin ≥9.5g/dL; The absolute count of neutrophils ≥1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤1.5 times the upper limit of normal value; Creatinine ≤1.25 times the upper limit of normal value; The creatinine clearance rate was ≥60ml/min; ⑤ Can obtain complete follow-up information, understand the situation of this study and sign informed consent. | |
| Screening of clinically cured patients with mild COVID-19 | ①Patients with mild COVID-19 cure were determined based on nucleic acid tests, CT examinations, and clinical criteria; ②Age > 18 years, age < 85 years, no gender restriction; ③ All had received COVID-19 drug therapy; ④ ECOG of general condition score: 0-2; No dysfunction of main viscera; Oxygen partial pressure ≥10.64kPa; White blood cells ≥4×109/L; Blood routine hemoglobin ≥9.5g/dL; The absolute count of neutrophils ≥1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤1.5 times the upper limit of normal value; Creatinine ≤1.25 times the upper limit of normal value; The creatinine clearance rate was ≥60ml/min; ⑤ Can obtain complete follow-up information, understand the situation of this study and sign informed consent. | |
| Healthy people who are not infected with COVID-19 | ① Volunteers who are not infected with COVID-19; ②Age > 18 years, age < 85 years, no gender restriction; ③ ECOG of general condition score: 0-2; No dysfunction of main viscera; Oxygen partial pressure ≥10.64kPa; White blood cells ≥4×109/L; Blood routine hemoglobin ≥9.5g/dL; The absolute count of neutrophils ≥1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤1.5 times the upper limit of normal value; Creatinine ≤1.25 times the upper limit of normal value; The creatinine clearance rate was ≥60ml/min; ④ Can obtain complete follow-up information, understand the situation of this study and sign informed consent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of clinically cured patients with severe COVID-19
Count the number of clinically cured patients with severe COVID-19
Measured: 6 months
Number of clinically cured patients with mild COVID-19
Count the number of clinically cured patients with mild COVID-19
Measured: 6 months
Number of healthy people who are not infected with COVID-19
Count the number of healthy people who are not infected with COVID-19
Measured: 6 months
Ki comparison between the severe, the mild and the healthy
Ki of the severe, the mild and the healthy were calculated and compared
Measured: 12 months
SUVmax comparison between the severe, the mild and the healthy
SUVmax of the severe, the mild and the healthy were calculated and compared
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PET/CTStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Shan, Ph.D, Study chair, Fifth Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519255
- Sponsor's protocol ID
- ZDWY.FZYX.008
- Status last verified
- Jul 2020
- First submitted
- 18 Aug 2020
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yao J, Liu J, Bi L, Huang Y, Wang L, Zhang F, Wang Y, Jin H. The imaging quantification of multiple organs by dynamic 18F-FDG PET/CT in discharged COVID-19 patients: A prospective pilot study. Int J Med Sci. 2022 Sep 6;19(10):1539-1547. doi: 10.7150/ijms.73801. eCollection 2022.
PubMed 36185330
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Open, Prospective, Randomized Pilot Study for Quantitative Analysis of Whole Body Inflammatory Lesions in Recovered COVID-19 Patients by 18F-FDG-PET/CT
- ClinicalTrials.gov ID
- NCT04519255
- Acronym / sponsor ID
- ZDWY.FZYX.008
- Conditions
- PET/CT, COVID-19, Respiratory Function, Inflammatory Lesions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 19 Aug 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.
In this study, clinically cured patients with severe COVID-19 were used to evaluate the therapeutic effect of COVID-19 and the recovery and health status of patients over time with highly sensitive PET/CT imaging technology. At the same time, PET/CT whole body scan, dynamic imaging and mathematical dynamic model were combined to evaluate the functions of the heart, lung, liver, kidney, brain and other important organs and the outcome of inflammatory lesions in clinically cured COVID-19 patients.
Detailed description
Covid-19 (Corona Virus Disease 2019, COVID-19), referred to as "COVID-19", refers to the pneumonia caused by novel Coronavirus 2019 (2019-NCOV/SARS-COV-2) infection. The clinical manifestations of the new patients were fever, fatigue and dry cough, while the symptoms of upper respiratory tract such as nasal congestion and runny nose were rare. Hypoxia occurs. About half of the patients developed dyspnea after one week, and in severe cases, the rapid progression was acute respiratory distress syndrome, septic shock, metabolic acidosis that was difficult to correct, and coagulation dysfunction. After the outbreak of COVID-19 in China, the National Health Commission issued the Diagnosis and Treatment Plan for COVID-19. By analyzing the epidemic situation and research progress, it organized experts to timely revise the diagnosis and treatment plan based on the analysis, study and summary of the previous medical treatment work.The discharge criteria for COVID-19 patients notified by the National Health Commission are remission of clinical symptoms, normal body temperature, normal CT, and negative nucleic acid tests for both tests. So far, the COVID-19 epidemic in China has been well under control. According to the latest statistics, 84,311 cases have been confirmed in total, and 1,433 cases have been confirmed so far.But studies (the latest from Dena Goffman's team, published in the NEJM) suggest that as many as 88 percent of coVID-19 patients are asymptomatic. Do cured patients leave the hospital with a percentage of asymptomatic patients?In addition, covid-19 cured patients in some regions turned positive again after discharge, indicating that long-term follow-up monitoring is of great significance for cured and discharged patients in addition to routine isolation observation!Moreover the literature at home and abroad other viral infections (such as hepatitis b, HIV, etc.) to cure patients found that the virus may lurk for a long time, the virus quantity contained in a very low level, the conventional detection method is difficult to detect, at the appropriate incentives can lead to attack, so for the new crown cure patients need close monitoring of systemic inflammation related lesions, and the situation of the latent virus.However, we still face many problems and challenges. For example, according to the latest data published by Dena Goffman's team in NEJM, the proportion of asymptomatic patients is as high as 88%, so the screening of asymptomatic patients is crucial.In many places, COVID-19 patients cured turn positive again after discharge. Therefore, it is of great significance to explore the mechanism of COVID-19 turning negative after discharge and evaluate the effect of novel Coronavirus and COVID-19 on patients' later recovery. Explore and develop more efficient and sensitive clinical detection methods to evaluate the treatment effect of covid-19 patients.
Positron emission computed tomography imaging technique is a nuclear medicine clinical diagnosis of advanced imaging techniques, can be shown on the in vivo biological molecules (such as 18 F- FDG, tracer nuclide labeled glucose molecules) metabolism, receptors and neurotransmitter activity of new functional imaging techniques, has been widely used in many kinds of disease diagnosis and differential diagnosis, a judgment, curative effect evaluation, viscera function research and development of new drugs, etc. Compared with traditional anatomical structure imaging, functional imaging PET has the following advantages: (1) High sensitivity. According to the test, PET molecular probe can pick up molecular events at the level of PM-NM in vivo. (2) High specificity, for the PET selected molecular probe, can only imaging the target molecules, for the same family of receptors, because the binding degree difference can be specifically distinguished; (3) Whole-body imaging, that is, one time PET imaging can obtain images of all regions of the whole body, and through the analysis can obtain the dynamic information of the metabolic changes of human tissues over time, which is of great significance for the research, prevention and evaluation of diseases.In particular, PET/CT scan provides a more reliable means of systemic monitoring for viruses that are lurking in all hidden parts of the body. (4) Security is good, although there are some radioactive nuclide PET need, but the amount of nuclide rarely used with short half-life, through two aspects of physical decay and biological metabolism function, in a very short time, client retention, a PET general inspection of radiation dose is far less than the conventional CT examination of a part, and safe and reliable.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Screening of clinically cured patients with severe COVID-19 | – | –①Patients with severe COVID-19 cure were determined based on nucleic acid tests, CT examinations, and clinical criteria; ②Age > 18 years, age < 85 years, no gender restriction; ③ All had received COVID-19 drug therapy; ④ ECOG of general condition score: 0-2; No dysfunction of main viscera; Oxygen partial pressure ≥10.64kPa; White blood cells ≥4×109/L; Blood routine hemoglobin ≥9.5g/dL; The absolute count of neutrophils ≥1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤1.5 times the upper limit of normal value; Creatinine ≤1.25 times the upper limit of normal value; The creatinine clearance rate was ≥60ml/min; ⑤ Can obtain complete follow-up information, understand the situation of this study and sign informed consent. |
| Screening of clinically cured patients with mild COVID-19 | – | –①Patients with mild COVID-19 cure were determined based on nucleic acid tests, CT examinations, and clinical criteria; ②Age > 18 years, age < 85 years, no gender restriction; ③ All had received COVID-19 drug therapy; ④ ECOG of general condition score: 0-2; No dysfunction of main viscera; Oxygen partial pressure ≥10.64kPa; White blood cells ≥4×109/L; Blood routine hemoglobin ≥9.5g/dL; The absolute count of neutrophils ≥1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤1.5 times the upper limit of normal value; Creatinine ≤1.25 times the upper limit of normal value; The creatinine clearance rate was ≥60ml/min; ⑤ Can obtain complete follow-up information, understand the situation of this study and sign informed consent. |
| Healthy people who are not infected with COVID-19 | – | –① Volunteers who are not infected with COVID-19; ②Age > 18 years, age < 85 years, no gender restriction; ③ ECOG of general condition score: 0-2; No dysfunction of main viscera; Oxygen partial pressure ≥10.64kPa; White blood cells ≥4×109/L; Blood routine hemoglobin ≥9.5g/dL; The absolute count of neutrophils ≥1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤1.5 times the upper limit of normal value; Creatinine ≤1.25 times the upper limit of normal value; The creatinine clearance rate was ≥60ml/min; ④ Can obtain complete follow-up information, understand the situation of this study and sign informed consent. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COVID-19 cured were determined based on nucleic acid tests, CT examinations, and clinical criteria. The age of patient were between 18 and 85 years, meanwhile in Zhuhai they were confirmed as COVID-19, cured and all received by COVID-19 drug therapy.
Key inclusion criteria (12 listed)
- Patients with severe COVID-19 cure were determined based on nucleic acid tests, CT examinations, and clinical criteria;
- Age > 18 years, age < 85 years, no gender restriction;
- All had received COVID-19 drug therapy;
- ECOG of general condition score: 0-2; No dysfunction of main viscera; Oxygen partial pressure ≥10.64kPa; White blood cells ≥4×109/L; Blood routine hemoglobin ≥9.5g/dL; The absolute count of neutrophils ≥1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤1.5 times the upper limit of normal value; Creatinine ≤1.25 times the upper limit of normal value; The creatinine clearance rate was ≥60ml/min;
- Can obtain complete follow-up information, understand the situation of this study and sign informed consent.
Key exclusion criteria (7 listed)
- Poorly controlled diabetics (fasting glucose level and GT;200 mg/dL);
- Any other malignancy within 5 years;
- Breastfeeding and/or pregnant women;
- Those who are prone to severe bleeding;
- Recent severe hemoptysis, severe cough, dyspnea or patients cannot cooperate;
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
Number of clinically cured patients with severe COVID-19
Time frame: 6 months
Count the number of clinically cured patients with severe COVID-19
Number of clinically cured patients with mild COVID-19
Time frame: 6 months
Count the number of clinically cured patients with mild COVID-19
Number of healthy people who are not infected with COVID-19
Time frame: 6 months
Count the number of healthy people who are not infected with COVID-19
Ki comparison between the severe, the mild and the healthy
Time frame: 12 months
Ki of the severe, the mild and the healthy were calculated and compared
SUVmax comparison between the severe, the mild and the healthy
Time frame: 12 months
SUVmax of the severe, the mild and the healthy were calculated and compared
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Derived from this study: PubMed 36185330Yao J, Liu J, Bi L, Huang Y, Wang L, Zhang F, Wang Y, Jin H. The imaging quantification of multiple organs by dynamic 18F-FDG PET/CT in discharged COVID-19 patients: A prospective pilot study. Int J Med Sci. 2022 Sep 6;19(10):1539-1547. doi: 10.7150/ijms.73801. eCollection 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.
Hong Shan, Ph.D study chair
Fifth Affiliated Hospital, Sun Yat-Sen University
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 PET/CT and COVID-19, run by Fifth Affiliated Hospital, Sun Yat-Sen University 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 12 inclusion and 7 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 5 Feb 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 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?
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?
Number of clinically cured patients with severe COVID-19 (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04519255, which also lists 1 linked publication.
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 5 Feb 2021.