Covid19Phase 1NCT04973735
A Phase I Study of LY-CovMab Injection in Chinese Healthy Subjects
A Phase 1 study testing LY-CovMab in people with Covid19, run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
A single center, randomized, doubled-blind, placebo-control and single ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of LY-CovMab Injection in Chinese healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- LY-CovMab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2020to 31 Jul 2021
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A signed informed consent form (ICF) from the patient or their legally authorized representative.
- Healthy males or females, ages ≥18 to ≤45 years. Male subjects with weight ≥50 kg, or female subjects with weight ≥45 kg, and body mass index (BMI) 19.0≤BMI≤26.0 kg/m2.
- No abnormality, or no clinically significant abnormality in vital signs, physical examination, laboratory tests, and 12-lead ECG in Chinese healthy subjects during the screening period.
- Female patients of childbearing potential (defined as female subjects who do not receive any operative sterilization or who had been through menopause for less than 1 year) must have a negative result for pregnancy test at screening. Male and female subjects with childbearing potential must agree to adopt effective contraceptive methods at least from 2 weeks prior to screening to 6 months after administration of the investigational drug.
Who cannot join
- Those who have had surgery within 8 weeks prior to screening or who have surgery planned during the trial, and the investigator believes that such surgery may bring potential risks to the subjects.
- Prior to administration of the investigational drug, use of the following drugs or therapies:
- any prescription drug within 28 days. ii. any over-the-counter drug, including health care products within 7 days.
- Prior history or current evidence of serious disease or chronic disease of the respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, immune system, hematology, psychiatry, and dermatology, etc, or any disease that may interfere with the trial results.
- Subjects with coronavirus disease 2019 (COVID-19) or recovered from it or subjects positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid or serum SARS-CoV-2 specific antibodies.
- Subjects who are with known history of allergies to any ingredient of the investigational drug, or similar drugs, or subjects with allergic constitution (previously sensitive to ≥ 2 foods or drugs).
Show all 13Show fewer
- Subjects with any positive test of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, treponema pallidum antibody, or human immunodeficiency virus (HIV) antibody.
- Subjects with alcohol abuse or tobacco abuse, or alcohol blood test results exceeding the upper limit of the normal range. Alcohol abuse is defined as: alcohol consumption of more than 14 U (1 U = 350 mL of beer, or 45 mL of liquor, or 150 mL of wine) per week within 3 months prior to screening. Tobacco abuse is defined as: smoking ≥5 cigarettes per day on average within 3 months prior to screening.
- Female subjects (including partners) who plan to be pregnant within one year upon screening, or pregnant or breast-feeding female subjects.
- Subjects with a history of drug addiction or drug abuse, or with positive urine screen test results for drug.
- Subjects donating whole blood or blood components, or with massive hemorrhage (>400 mL), within 3 months prior to screening.
- Prior vaccination with SARS-CoV-2 vaccine or participation in a SARS-CoV-2 neutralizing antibody clinical trial. Participation in any other clinical study with pharmacological intervention within 3 months prior to screening, or the drug is still within the elimination period (5 half-lives) prior to screening, whichever is longer. Vaccination within 12 weeks prior to screening, or planned vaccination during the study and within 12 weeks after the end of the study.
- Subjects with a history of fainting at the sight of blood or puncture. Subjects who are not suitable to participate in the clinical trial as considered by the investigator or cannot complete the study for any other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
About this study
Official title: A Phase I, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of LY-CovMab Injection in Chinese Healthy Subjects
A single center, randomized, doubled-blind, placebo-control and single ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of LY-CovMab Injection in Chinese healthy subjects.
Read the detailed description
A single center, randomized, doubled-blind, placebo-control and single ascending dose phase I study:
Primary objective: to evaluate the safety and tolerability of a single dose of LY-CovMab Injection in Chinese healthy subjects.
Secondary objective: to evaluate the pharmacokinetics (PK) and immunogenicity of a single dose of LY-CovMab injection in Chinese healthy subjects.
- Conditions
- Covid19
- Being tested
- LY-CovMab
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY-CovMabDrug
single IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 30mg LY-CovMab | Experimental | LY-CovMab is diluted with 0.9% sodium chloride to a total volume of 250 mL for IV infusion Receives: Drug: LY-CovMab |
| 150mg LY-CovMab | Experimental | LY-CovMab is diluted with 0.9% sodium chloride to a total volume of 250 mL for IV infusion Receives: Drug: LY-CovMab |
| 600mg LY-CovMab | Experimental | LY-CovMab is diluted with 0.9% sodium chloride to a total volume of 250 mL for IV infusion Receives: Drug: LY-CovMab |
| 1200mg LY-CovMab | Experimental | LY-CovMab is diluted with 0.9% sodium chloride to a total volume of 250 mL for IV infusion Receives: Drug: LY-CovMab |
| 2400mg LY-CovMab | Experimental | LY-CovMab is diluted with 0.9% sodium chloride to a total volume of 250 mL for IV infusion Receives: Drug: LY-CovMab |
| Placebo | Placebo comparator | Placebo is diluted with 0.9% sodium chloride to a total volume of 250 mL for IV infusion Receives: Drug: LY-CovMab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent Changes in Body Temperature
Grade of treatment-emergent changes in body temperature by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).
Measured: up to 99 days
Treatment-emergent Changes in Respiratory Rate
Grade of treatment-emergent changes in respiratory rate by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).
Measured: up to 99 days
Treatment-emergent Changes in Pulse Rate
Grade of treatment-emergent changes in pulse rate by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).
Measured: up to 99 days
Treatment-emergent Changes in Blood Pressure
Grade of treatment-emergent changes in blood pressure by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).
Measured: up to 99 days
Safety Laboratory Value (Haematology)
Haematology laboratory value by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0 (absolute and change from baseline where identified). The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).
Measured: D-1, D4, D8, D15, D29, D50, D99
Safety Laboratory Value (blood chemistry)
Serum Chemistry laboratory value by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0 (absolute and change from baseline where identified). The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).
Measured: D-1, D4, D8, D15, D29, D50, D99
Frequency and Grade of Adverse Events
Measured: up to 99 days
Assess safety profile of LY-CovMab
12 lead electrocardiogram (ECG) heart rate
Measured: D-1, D4, D8, D15, D29, D50, D99
Assess safety profile of LY-CovMab
12 lead electrocardiogram (ECG) PR interval
Measured: D-1, D4, D8, D15, D29, D50, D99
Assess safety profile of LY-CovMab
12 lead electrocardiogram (ECG) QTc interval
Measured: D-1, D4, D8, D15, D29, D50, D99
Assess safety profile of LY-CovMab
12 lead electrocardiogram (ECG) QRS interval
Measured: D-1, D4, D8, D15, D29, D50, D99
Secondary outcomes (10)
Assess Pharmacokinetic parameters of LY-CovMab
Maximum observed concentration (Cmax)
Measured: up to 99 days
Assess Pharmacokinetic parameters of LY-CovMab
Time to maximum observed concentration (Tmax)
Measured: up to 99 days
Assess Pharmacokinetic parameters of LY-CovMab
Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0 last)
Measured: up to 99 days
Assess Pharmacokinetic parameters of LY-CovMab
Percentage of the extrapolated area under the concentration-time curve (AUC_%Extrap)
Measured: up to 99 days
Assess Pharmacokinetic parameters of LY-CovMab
Area under the concentration-time curve from time 0 to infinity (AUC0-inf),
Measured: up to 99 days
Assess Pharmacokinetic parameters of LY-CovMab
Clearance (CL)
Measured: up to 99 days
Assess Pharmacokinetic parameters of LY-CovMab
Half-life (t1/2)
Measured: up to 99 days
Assess Pharmacokinetic parameters of LY-CovMab
Volume of distribution (Vd)
Measured: up to 99 days
Assess the immunogenicity of LY-CovMab
Incidence of anti-drug antibody (ADA)
Measured: D1, D15, D29, D43, D57, D71, D99
Assess the immunogenicity of LY-CovMab
Incidence of neutralizing antibody (Nab)
Measured: D1, D15, D29, D43, D57, D71, D99
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start10 Nov 2020
- Primary completion1 May 2021
- Study completion31 Jul 2021 (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 Covid19Studies of the same condition, open and under way.
- More trials run by Luye Pharma Group Ltd.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shandong Boan Biotechnology Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Hui Zhao, Dr, Principal investigator, The Second Hospital of Anhui Medical UniversityWei Hu, Dr, Principal investigator, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973735
- Sponsor's protocol ID
- LY-CovMab/CT-CHN-101
- Status last verified
- Jul 2021
- First submitted
- 30 Jun 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Q, Zhou R, Yang J, Dou C, Gan T, Liu F, Hu B, Song D, Lu C, Hu W. A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Clinical Trial to Assess Safety, Tolerability, and Pharmacokinetics of LY-CovMab, a Potent Human Neutralizing Antibody Against SARS-CoV-2. Infect Dis Ther. 2022 Feb;11(1):405-422. doi: 10.1007/s40121-021-00572-x. Epub 2021 Dec 8.
PubMed 34878625
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of LY-CovMab Injection in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT04973735
- Acronym / sponsor ID
- LY-CovMab/CT-CHN-101
- Conditions
- Covid19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shandong Boan Biotechnology Co., Ltd
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 22 Jul 2021 (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.
A single center, randomized, doubled-blind, placebo-control and single ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of LY-CovMab Injection in Chinese healthy subjects.
Detailed description
A single center, randomized, doubled-blind, placebo-control and single ascending dose phase I study:
Primary objective: to evaluate the safety and tolerability of a single dose of LY-CovMab Injection in Chinese healthy subjects.
Secondary objective: to evaluate the pharmacokinetics (PK) and immunogenicity of a single dose of LY-CovMab injection in Chinese healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 30mg LY-CovMab | Experimental | Drug: LY-CovMabLY-CovMab is diluted with 0.9% sodium chloride to a total volume of 250 mL for IV infusion |
| 150mg LY-CovMab | Experimental | Drug: LY-CovMabLY-CovMab is diluted with 0.9% sodium chloride to a total volume of 250 mL for IV infusion |
| 600mg LY-CovMab | Experimental | Drug: LY-CovMabLY-CovMab is diluted with 0.9% sodium chloride to a total volume of 250 mL for IV infusion |
| 1200mg LY-CovMab | Experimental | Drug: LY-CovMabLY-CovMab is diluted with 0.9% sodium chloride to a total volume of 250 mL for IV infusion |
| 2400mg LY-CovMab | Experimental | Drug: LY-CovMabLY-CovMab is diluted with 0.9% sodium chloride to a total volume of 250 mL for IV infusion |
| Placebo | Placebo comparator | Drug: LY-CovMabPlacebo is diluted with 0.9% sodium chloride to a total volume of 250 mL for IV infusion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- A signed informed consent form (ICF) from the patient or their legally authorized representative.
- Healthy males or females, ages ≥18 to ≤45 years. Male subjects with weight ≥50 kg, or female subjects with weight ≥45 kg, and body mass index (BMI) 19.0≤BMI≤26.0 kg/m2.
- No abnormality, or no clinically significant abnormality in vital signs, physical examination, laboratory tests, and 12-lead ECG in Chinese healthy subjects during the screening period.
- Female patients of childbearing potential (defined as female subjects who do not receive any operative sterilization or who had been through menopause for less than 1 year) must have a negative result for pregnancy test at screening. Male and female subjects with childbearing potential must agree to adopt effective contraceptive methods at least from 2 weeks prior to screening to 6 months after administration of the investigational drug.
Key exclusion criteria (13 listed)
- Those who have had surgery within 8 weeks prior to screening or who have surgery planned during the trial, and the investigator believes that such surgery may bring potential risks to the subjects.
- Prior to administration of the investigational drug, use of the following drugs or therapies:
- any prescription drug within 28 days. ii. any over-the-counter drug, including health care products within 7 days.
- Prior history or current evidence of serious disease or chronic disease of the respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, immune system, hematology, psychiatry, and dermatology, etc, or any disease that may interfere with the trial results.
- Subjects with coronavirus disease 2019 (COVID-19) or recovered from it or subjects positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid or serum SARS-CoV-2 specific antibodies.
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 |
|---|---|---|
| LY-CovMabsingle IV infusion | Drug | 1200mg LY-CovMab, 150mg LY-CovMab, 2400mg LY-CovMab, 30mg LY-CovMab, 600mg LY-CovMab, Placebo |
Primary outcome
Treatment-emergent Changes in Body Temperature
Time frame: up to 99 days
Grade of treatment-emergent changes in body temperature by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).
Treatment-emergent Changes in Respiratory Rate
Time frame: up to 99 days
Grade of treatment-emergent changes in respiratory rate by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).
Treatment-emergent Changes in Pulse Rate
Time frame: up to 99 days
Grade of treatment-emergent changes in pulse rate by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).
Treatment-emergent Changes in Blood Pressure
Time frame: up to 99 days
Grade of treatment-emergent changes in blood pressure by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).
Safety Laboratory Value (Haematology)
Time frame: D-1, D4, D8, D15, D29, D50, D99
Haematology laboratory value by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0 (absolute and change from baseline where identified). The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).
Safety Laboratory Value (blood chemistry)
Time frame: D-1, D4, D8, D15, D29, D50, D99
Serum Chemistry laboratory value by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0 (absolute and change from baseline where identified). The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).
Frequency and Grade of Adverse Events
Time frame: up to 99 days
Assess safety profile of LY-CovMab
Time frame: D-1, D4, D8, D15, D29, D50, D99
12 lead electrocardiogram (ECG) heart rate
Assess safety profile of LY-CovMab
Time frame: D-1, D4, D8, D15, D29, D50, D99
12 lead electrocardiogram (ECG) PR interval
Assess safety profile of LY-CovMab
Time frame: D-1, D4, D8, D15, D29, D50, D99
12 lead electrocardiogram (ECG) QTc interval
Assess safety profile of LY-CovMab
Time frame: D-1, D4, D8, D15, D29, D50, D99
12 lead electrocardiogram (ECG) QRS interval
10 secondary outcomes
Assess Pharmacokinetic parameters of LY-CovMab
Time frame: up to 99 days
Assess Pharmacokinetic parameters of LY-CovMab
Time frame: up to 99 days
Assess Pharmacokinetic parameters of LY-CovMab
Time frame: up to 99 days
Assess Pharmacokinetic parameters of LY-CovMab
Time frame: up to 99 days
Assess Pharmacokinetic parameters of LY-CovMab
Time frame: up to 99 days
Assess Pharmacokinetic parameters of LY-CovMab
Time frame: up to 99 days
Assess Pharmacokinetic parameters of LY-CovMab
Time frame: up to 99 days
Assess Pharmacokinetic parameters of LY-CovMab
Time frame: up to 99 days
Assess the immunogenicity of LY-CovMab
Time frame: D1, D15, D29, D43, D57, D71, D99
Assess the immunogenicity of LY-CovMab
Time frame: D1, D15, D29, D43, D57, D71, D99
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Derived from this study: PubMed 34878625Zhang Q, Zhou R, Yang J, Dou C, Gan T, Liu F, Hu B, Song D, Lu C, Hu W. A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Clinical Trial to Assess Safety, Tolerability, and Pharmacokinetics of LY-CovMab, a Potent Human Neutralizing Antibody Against SARS-CoV-2. Infect Dis Ther. 2022 Feb;11(1):405-422. doi: 10.1007/s40121-021-00572-x. Epub 2021 Dec 8.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Hui Zhao, Dr principal investigator
The Second Hospital of Anhui Medical University
Wei Hu, Dr principal investigator
The Second Hospital of Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY-CovMab in people with Covid19, run by Luye Pharma Group Ltd. 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 4 inclusion and 13 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 22 Jul 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Treatment-emergent Changes in Body Temperature (time frame: up to 99 days). The study lists 11 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 NCT04973735, 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 22 Jul 2021.