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| ID | Type | Description | Link |
|---|---|---|---|
| NCT05263908 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this post marketing observational study is to learn about the safety and effects of the commercial medicine (called PAXLOVID) for the treatment of COVID-19. This study is intended to be registered with the participants who:
All participants will receive PAXLOVID, a standard treatment for COVID-19. Participants will take PAXLOVID 2 times a day by mouth or as prescribed.
We will examine the experiences of people taking PAXLOVID. This will help us determine if PAXLOVID is safe and effective.
Participants will be followed up for 28 days after taking PAXLOVID. During this time, participants will be closely watched for the safety and effects of PAXLOVID.
This is a multicenter cohort study to be conducted in individuals with SARS-CoV-2 infection who are treated with this product, and the investigator will enter the information required in this study in the case report forms (CRFs) based on the information obtained through medical records.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAXLOVID PACK | Subjects administered PAXLOVID PACK |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nirmatrelvir / ritonavir | Drug | The usual dosage in adults and pediatric patients (≥12 years of age weighing ≥40 kg) is 300 mg of Nirmatrelvir and 100 mg of ritonavir all taken together orally twice daily for 5 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Drug Reactions | Adverse drug reaction (ADR) was a treatment-related adverse event and any untoward medical occurrence attributed to Paxlovid PACK in a participant who received Paxlovid PACK. Serious adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Paxlovid PACK was assessed by the physician. | From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Worsening Severity (Efficacy Analysis Set #1) | Whether the severity of infection caused by SARS-CoV-2 had worsened was evaluated. However, when the severity was severe at the start of Paxlovid PACK and did not worsen during the observation period, it was considered as "severe at the start of treatment." | From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45 days. |
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Inclusion Criteria:
Exclusion Criteria:
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The subjects who have been treated with PAXLOVID PACK for the first time.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Local County | Tokyo | 1518589 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41621946 | Derived | Murata K, Hyokai S, Fujii Y, Morimasa M. Real-world safety of nirmatrelvir plus ritonavir in patients with COVID-19 in Japan: A post-marketing surveillance study. Jpn J Infect Dis. 2026 Jan 30. doi: 10.7883/yoken.JJID.2024.380. Online ahead of print. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paxlovid PACK (Nirmatrelvir/Ritonavir) | Participants who received Paxlovid PACK as indicated in the approved local product document for the first time were observed from the start date of treatment with Paxlovid PACK to 28 days after the end of treatment (the day following the end of treatment was defined as Day 1). The dosage can be adjusted as per physician's discretion. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 2948 participants completed the study. Of the 2948 participants, 119 participants were excluded from the safety analysis set due to the following reasons: no information on administration (13 participants), no information on adverse events - no re-visits (106 participants). Overall, the safety analysis set comprised of 2829 participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Paxlovid PACK (Nirmatrelvir/Ritonavir) | Participants who received Paxlovid PACK as indicated in the approved local product document for the first time were observed from the start date of treatment with Paxlovid PACK to 28 days after the end of treatment (the day following the end of treatment was defined as Day 1). The dosage can be adjusted as per physician's discretion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Adverse Drug Reactions | Adverse drug reaction (ADR) was a treatment-related adverse event and any untoward medical occurrence attributed to Paxlovid PACK in a participant who received Paxlovid PACK. Serious adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Paxlovid PACK was assessed by the physician. | The safety analysis set (2829 participants) comprised of participants who satisfied the inclusion criteria. Participants with no informed consent for publication of study results, no information on administration, and no information on adverse events - no re-visits were excluded. | Posted | Count of Participants | Participants | From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45 days. |
|
From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paxlovid PACK (Nirmatrelvir/Ritonavir) | Participants who received Paxlovid PACK as indicated in the approved local product document for the first time were observed from the start date of treatment with Paxlovid PACK to 28 days after the end of treatment (the day following the end of treatment was defined as Day 1). The dosage can be adjusted as per physician's discretion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA/J26.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA/J26.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 31, 2023 | Jul 9, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 8, 2023 | Jul 9, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000719967 | nirmatrelvir and ritonavir drug combination |
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|
| Percentage of Participants With Worsening Severity (Efficacy Analysis Set #2) | Whether the severity of infection caused by SARS-CoV-2 had worsened was evaluated. However, when the severity was severe at the start of Paxlovid PACK and did not worsen during the observation period, it was considered as "severe at the start of treatment." | From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 35 days. |
| Percentage of Participants With Worsening Severity (Efficacy Analysis Set #3) | Whether the severity of infection caused by SARS-CoV-2 had worsened was evaluated. However, when the severity was severe at the start of Paxlovid PACK and did not worsen during the observation period, it was considered as "severe at the start of treatment." | From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 35 days. |
| Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Efficacy Analysis Set #3) | The percent probability is the percent of the participants who had COVID-19 related hospitalization or death from any cause. | 3, 5, 7, 14, 21 and 28 days after the start of administration with Paxlovid PACK. |
| Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Sensitivity Analysis) (Efficacy Analysis Set #3) | The percent probability is the percent of the participants who had COVID-19 related hospitalization or death from any cause. Sensitivity analysis was conducted by changing the event definition of "hospitalization for treatment of infection caused by SARS-CoV-2" as follows: there were concomitant medications for infection caused by SARS-CoV-2 or concomitant non-drug therapies due to infection caused by SARS-CoV-2 on or after the date of administration. | 3, 5, 7, 14, 21 and 28 days after the start of administration with Paxlovid PACK. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG000 |
| Paxlovid PACK (Nirmatrelvir/Ritonavir) |
Participants who received Paxlovid PACK as indicated in the approved local product document for the first time were observed from the start date of treatment with Paxlovid PACK to 28 days after the end of treatment (the day following the end of treatment was defined as Day 1). The dosage can be adjusted as per physician's discretion. |
|
|
| Secondary | Percentage of Participants With Worsening Severity (Efficacy Analysis Set #1) | Whether the severity of infection caused by SARS-CoV-2 had worsened was evaluated. However, when the severity was severe at the start of Paxlovid PACK and did not worsen during the observation period, it was considered as "severe at the start of treatment." | For the efficacy analysis set #1 (2828 participants), participant with disease not subject to the study (1 participant) was excluded from the safety analysis set. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45 days. |
|
|
|
| Secondary | Percentage of Participants With Worsening Severity (Efficacy Analysis Set #2) | Whether the severity of infection caused by SARS-CoV-2 had worsened was evaluated. However, when the severity was severe at the start of Paxlovid PACK and did not worsen during the observation period, it was considered as "severe at the start of treatment." | For the efficacy analysis set #2 (1965 participants), participants other than outpatient at the start of treatment (863 participants) were excluded from the efficacy analysis set #1. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 35 days. |
|
|
|
| Secondary | Percentage of Participants With Worsening Severity (Efficacy Analysis Set #3) | Whether the severity of infection caused by SARS-CoV-2 had worsened was evaluated. However, when the severity was severe at the start of Paxlovid PACK and did not worsen during the observation period, it was considered as "severe at the start of treatment." | For the efficacy analysis set #3 (1905 participants), participants with no risk factors of progressing to severe illness (60 participants) were excluded from the efficacy analysis set #2. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 35 days. |
|
|
|
| Secondary | Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Efficacy Analysis Set #3) | The percent probability is the percent of the participants who had COVID-19 related hospitalization or death from any cause. | For the efficacy analysis set #3 (1905 participants), participants with no risk factors of progressing to severe illness (60 participants) were excluded from the efficacy analysis set #2. | Posted | Number | 95% Confidence Interval | Percent probability | 3, 5, 7, 14, 21 and 28 days after the start of administration with Paxlovid PACK. |
|
|
|
| Secondary | Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Sensitivity Analysis) (Efficacy Analysis Set #3) | The percent probability is the percent of the participants who had COVID-19 related hospitalization or death from any cause. Sensitivity analysis was conducted by changing the event definition of "hospitalization for treatment of infection caused by SARS-CoV-2" as follows: there were concomitant medications for infection caused by SARS-CoV-2 or concomitant non-drug therapies due to infection caused by SARS-CoV-2 on or after the date of administration. | For the efficacy analysis set #3 (1905 participants), participants with no risk factors of progressing to severe illness (60 participants) were excluded from the efficacy analysis set #2. | Posted | Number | 95% Confidence Interval | Percent probability | 3, 5, 7, 14, 21 and 28 days after the start of administration with Paxlovid PACK. |
|
|
|
| 16 |
| 2,829 |
| 51 |
| 2,829 |
| 474 |
| 2,829 |
| Cardiac failure acute | Cardiac disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Mechanical ileus | Gastrointestinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Cholangitis acute | Hepatobiliary disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA/J26.0 | Non-systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA/J26.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA/J26.0 | Non-systematic Assessment |
|
| Escherichia bacteraemia | Infections and infestations | MedDRA/J26.0 | Non-systematic Assessment |
|
| Klebsiella infection | Infections and infestations | MedDRA/J26.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA/J26.0 | Non-systematic Assessment |
|
| Pneumonia aspiration | Infections and infestations | MedDRA/J26.0 | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA/J26.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA/J26.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Immobilisation syndrome | Musculoskeletal and connective tissue disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J26.0 | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J26.0 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J26.0 | Non-systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J26.0 | Non-systematic Assessment |
|
| Malignant neoplasm of unknown primary site | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J26.0 | Non-systematic Assessment |
|
| Cerebral venous thrombosis | Nervous system disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Respiration abnormal | Respiratory, thoracic and mediastinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Faeces soft | Gastrointestinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Oral discomfort | Gastrointestinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA/J26.0 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA/J26.0 | Non-systematic Assessment |
|
| Pneumonia aspiration | Infections and infestations | MedDRA/J26.0 | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA/J26.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA/J26.0 | Non-systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA/J26.0 | Non-systematic Assessment |
|
| Fibrin D dimer increased | Investigations | MedDRA/J26.0 | Non-systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA/J26.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Olfactory dysfunction | Nervous system disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Taste disorder | Nervous system disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
|
| Unknown (worsening unknown) |
|
|
| Unknown (worsening unknown) |
|
|
| Unknown (worsening unknown) |
|
|
| 14 days from the start of administration of this drug |
|
| 21 days from the start of administration of this drug |
|
| 28 days from the start of administration of this drug |
|
|
| 14 days from the start of administration of this drug |
|
| 21 days from the start of administration of this drug |
|
| 28 days from the start of administration of this drug |
|