COVID-19 Clinical Trial
Official title:
Phase 1, Open-Label, Randomized Study of the Safety and Immunogenicity of a SARS-CoV-2 Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults
| Verified date | April 6, 2021 |
| Source | National Institute of Allergy and Infectious Diseases (NIAID) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a phase 1, open-label, randomized clinical trial in males and non-pregnant females, 18 years of age and older, who are in good health, have no known history of COVID-19 or SARS-CoV-2 infection, and meet all other eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273.351 manufactured by ModernaTX, Inc, given in vaccination schedules alone, sequentially, or coadministered with mRNA-1273. mRNA-1273.351 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized S protein of the SARS-CoV-2 B.1.351 variant. Enrollment will occur at approximately five domestic clinical research sites. This study includes two cohorts. Cohort 1 will provide rapid information about the immunogenicity of mRNA-1273.351 in a previously vaccinated group. This cohort can inform near term public health decisions if the variant virus becomes more widespread. Cohort 2 will evaluate different strategies for generation of cross protective immune responses in a naïve population. This cohort will take longer to provide information on the immunogenicity of mRNA-1273.351, but is important to inform future public health strategies. Cohort 1 will include approximately 60 subjects 18 years of age and older who received two vaccinations of mRNA-1273 at dosages of 50 mcg, 100 mcg, or 250 mcg in the Phase 1 clinical trial (DMID 20-0003). Subjects in Cohort 1 will receive a single intramuscular (IM) injection of the designated vaccine and will be followed through 12 months after vaccination. Follow-up visits will occur on Days 8, 15, and 29, as well as 3, 6, and 12 months after the vaccination. Cohort 2 will include approximately 150 participants 18 through 55 years of age who have not received a COVID-19 vaccine, have no known history of COVID-19 or SARS-CoV-2 infection, and do not have underlying conditions that are associated with an increased risk of severe illness from SARS-CoV-2 infection. Enrollment may close before the full 150 participants based on estimates on the timing of immunogenicity results and the need to inform public health decisions. They will be randomly assigned to one of 8 treatment arms and will receive 2 or 3 IM injections of the vaccine and followed through 12 months after the last vaccination. Follow-up visits will occur 7, 14, and 28 days after each vaccination, as well as 3, 6 and 12 months post the last vaccination. The primary objective is to evaluate the safety and reactogenicity of mRNA-1273 and mRNA-1273.351 vaccines, in naïve and previously vaccinated individuals.
| Status | Completed |
| Enrollment | 135 |
| Est. completion date | July 5, 2022 |
| Est. primary completion date | July 5, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility | Inclusion Criteria: 1. Provides written informed consent prior to initiation of any study procedures. 2. Be able to understand and agrees to comply with planned study procedures and be available for all study visits. 3. Agrees to the collection of venous blood per protocol. 4. Cohort 1: previously received 2 doses of mRNA-1273 intramuscular (IM) as part of DMID 20-0003. 5. Cohort 1: Male or non-pregnant female, >/= 18 years of age at time of enrollment. Cohort 2: Male or non-pregnant female, 18 through 55 years of age at time of enrollment. 6. Women of childbearing potential* must agree to practice abstinence or use at least one acceptable primary form of contraception.**, *** Note: These criteria are applicable to females in a heterosexual relationship and child-bearing potential (i.e., the criteria do not apply to subjects in a same sex relationship). * Not of childbearing potential - post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy, or Essure(R) placement). ** Acceptable forms of primary contraception include monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to the subject's first vaccination, intrauterine devices, birth control pills, and injectable/implantable/insertable hormonal birth control products. *** Must use at least one acceptable primary form of contraception for at least 30 days prior to the first vaccination and at least one acceptable primary form of contraception for 60 days after the last vaccination. 7. In good health.* * As determined by medical history and physical examination to evaluate acute or ongoing chronic medical diagnoses/conditions that have been present for at least 90 days, which would affect the assessment of safety of subjects. Chronic medical diagnoses/conditions should be stable for the last 60 days (no hospitalizations, emergency room, or urgent care for condition or need for supplemental oxygen). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis/condition in the 60 days before enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or done for financial reasons, and in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome or for dose optimization, as determined by the participating site PI or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the participating site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity, and do not indicate a worsening of medical diagnosis/condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided the change was not precipitated by deterioration in the chronic medical condition, and there is no anticipated additional risk to the subject or interference with the evaluation of responses to study vaccination. 8. Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius). 9. Must agree to have samples stored for secondary research. 10. Agrees to adhere to Lifestyle Considerations throughout study duration. 11. Must agree to refrain from donating blood or plasma during the study (outside of this study). Exclusion Criteria: 1. Positive pregnancy test prior to each vaccine administration. 2. BMI > 40.0 kg / m^2. 3. Female subject who is breastfeeding. 4. Has any medical disease or condition that, in the opinion of the participating site PI or appropriate sub-investigator, precludes study participation.* * Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial. 5. Presence of self-reported or medically documented significant medical or psychiatric condition(s).* * Significant medical or psychiatric conditions include but are not limited to: Respiratory disease (e.g., chronic obstructive pulmonary disease [COPD], asthma) requiring daily medications currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years. Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short acting beta agonists, theophylline, ipratropium, biologics. Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease), history of myocarditis or pericarditis as an adult, myocardial infarction (MI) within past 6 months, coronary artery bypass surgery or stent placement, or uncontrolled cardiac arrhythmia. Neurological or neurodevelopmental conditions (e.g., history of migraines in the past 5 years, epilepsy, stroke, seizures in the last 3 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis, transverse myelitis, stroke or transient ischemic attack, multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis, Creutzfeldt-Jakob disease, or Alzheimer's disease). Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed. An autoimmune disease, including hypothyroidism without a defined non-autoimmune cause, localized or history of psoriasis. An immunodeficiency of any cause. Chronic kidney disease, estimated glomerular filtration rate (eGFR) < 60 mL / min / 1.73m^2. Type 2 diabetes mellitus, not including prediabetes. 6. Has an acute illness*, as determined by the participating site PI or appropriate sub-investigator, with or without fever [oral temperature >/= 38.0 degrees Celsius (100.4 degrees Fahrenheit)] within 72 hours prior to each vaccination. * An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the participating site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol. 7. Has participated in another investigational study involving any investigational product* within 5 half-lives before the first vaccine administration. * study drug, biologic or device. 8. Currently enrolled in or plans to participate in another clinical trial with an investigational agent* that will be received during the study-reporting period.** * Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication. ** Up to 15 months after the first vaccination. 9. Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to drugs or any previous licensed or unlicensed vaccines or to polyethylene glycol (PEG) or a PEG-containing product. 10. Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness.* * Including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs during the preceding 6-month period prior to vaccine administration (Day 1). The use of low dose topical, ophthalmic, inhaled and intranasal steroid preparations will be permitted. 11. Anticipating the need for immunosuppressive treatment within the next 6 months. 12. Received immunoglobulins and/or any blood or blood products within the 4 months before the first vaccine administration or at any time during the study. 13. Has any blood dyscrasias or significant disorder of coagulation. 14. Received or plans to receive a licensed, live vaccine within 4 weeks before or after each vaccination. 15. Received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after each vaccination. 16. Receipt of any other SARS-CoV-2 vaccine or any experimental coronavirus vaccine at any time prior to or during the study, except Cohort 1 subjects who received mRNA-1273 in DMID 20-0003. 17. Close contact of anyone known to have SARS-CoV-2 infection within 14 days prior to vaccine administration. 18. History of COVID-19 diagnosis, positive SARS-CoV-2 PCR test, or, for Cohort 2 only, a known positive SARS-CoV-2 serologic test. 19. On current treatment with investigational agents for prophylaxis of COVID-19. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Cincinnati Children's Hospital Medical Center Vaccine Research Center | Cincinnati | Ohio |
| United States | The Hope Clinic of Emory University | Decatur | Georgia |
| United States | Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center | Nashville | Tennessee |
| United States | Kaiser Permanente Washington Health Research Institute | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | ModernaTX, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Any Medically-attended Adverse Events (MAAEs) | Number of participants that experienced MAAEs during the course of the study. | Day 1 to study completion, up to 1 year post last dose | |
| Primary | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | Number of participants that experienced any NOCMCs during the course of the study. | Day 1 to study completion, up to 1 year post last dose | |
| Primary | Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs) | Number of participants that experienced any AESIs during the course of the study. An adverse event of special interest (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is required. AESIs include anosmia, ageusia, subacute thyroiditis, acute pancreatitis, appendicitis, rhabdomyolysis, acute respiratory distress syndrome, coagulation disorders, acute cardiovascular injury, acute kidney injury, acute liver injury, dermatologic findings, multisystem inflammatory disorders, thrombocytopenia, acute aseptic arthritis, new onset of or worsening of neurologic disease, anaphylaxis, and other syndromes. | Day 1 to study completion, up to 1 year post last dose | |
| Primary | Frequency of Any Serious Adverse Events (SAEs) | The number of participants that experience any SAEs from Day 1 to study completion. An AE or suspected adverse reaction is considered serious if, in the view of either the participating site PI or appropriate sub-investigator or the sponsor, it results in: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. | Day 1 to study completion, up to 1 year post last dose | |
| Primary | Frequency of Solicited Reactogenicity Adverse Events (AEs) | The number of participants that experienced at least one solicited (local and systemic) AE through 7 days post vaccination. Systemic events include: fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. | Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, Day 57-64 for Arms 2A-2B | |
| Primary | Grade of Solicited Reactogenicity Adverse Events (AEs) | Number of participants who experienced any solicited (local and systemic) AEs through 7 days post vaccination by grade. Systemic events include: fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. | Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, Day 57-64 for Arms 2A-2B | |
| Primary | Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study Product | Number of events of any unsolicited AE through 28 days post vaccination by relationship to study product and severity, experienced by participants in the Safety Analysis population. Unsolicited AEs were events that were spontaneously reported by the subject, or revealed by observation, physical examination or other diagnostic procedures. | Day 1 through Day 29 for Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, Day 57 through Day 85 from Arms 2A-2B | |
| Primary | Grade of Any Unsolicited Adverse Events (AEs) | Number of any unsolicited AEs through 28 days post vaccination by severity. | Day 1 through Day 29 for Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, Day 57 through Day 85 from Arms 2A-2B | |
| Secondary | Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1B | Geometric mean titer (GMT) of antibody against WA-1 S2-P using a 4-plex ECLIA Assay. | Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366 | |
| Secondary | Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2B | Geometric mean titer (GMT) of antibody against WA-1 S2-P using a 4-plex ECLIA Assay. | Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422 | |
| Secondary | Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-H | Geometric mean titer (GMT) of antibody against WA-1 S2-P using a 4-plex ECLIA Assay | Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394 | |
| Secondary | Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1B | Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P using a 4-plex ECLIA Assay. | Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366 | |
| Secondary | Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2B | Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P using a 4-plex ECLIA Assay. | Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422 | |
| Secondary | Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-H | Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P using a 4-plex ECLIA Assay. | Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394 | |
| Secondary | Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 1A and 1B | Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P. | Day 15, Day 29, Day 91, Day 181, Day 366 | |
| Secondary | Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2B | Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P. | Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422 | |
| Secondary | Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-H | Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P. | Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394 | |
| Secondary | Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 1A and 1B | Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.351 S2-P. | Day 15, Day 29, Day 91, Day 181, Day 366 | |
| Secondary | Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2B | Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.351 S2-P. | Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422 | |
| Secondary | Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-H | Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.351 S2-P. | Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394 | |
| Secondary | Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1B | Geometric Mean (GM) of Pseudovirus Neutralization Against D614G. | Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366 | |
| Secondary | Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2B | Geometric Mean (GM) of Pseudovirus Neutralization Against D614G | Day 1 Pre-Dose, Day 29, Day 57, Day 85, Day 147, Day 237, Day 422 | |
| Secondary | Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-H | Geometric Mean (GM) of Pseudovirus Neutralization Against D614G. Arms 2C and 2G Day 43 samples were used for pseudovirus neutralization assay validation and results included for completeness. Samples for other vaccination groups at Day 43 were not tested for neutralization. | Day 1 Pre-Dose, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394 | |
| Secondary | Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1B | Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351. | Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366 | |
| Secondary | Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2B | Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 | Day 1 Pre-Dose, Day 29, Day 57, Day 85, Day 147, Day 237, Day 422 | |
| Secondary | Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-H | Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351. Arms 2C and 2G Day 43 samples were used for pseudovirus neutralization assay validation and results included for completeness. Samples for other vaccination groups at Day 43 were not tested for neutralization. | Day 1 Pre-Dose, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394 | |
| Secondary | Number of Participants Who Seroconverted Against D614G for Arms 1A and 1B | Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against D614G. | Day 15, Day 29, Day 91, Day 181, Day 366 | |
| Secondary | Number of Participants Who Seroconverted Against D614G for Arms 2A and 2B | Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against D614G. | Day 29, Day 57, Day 85, Day 147, Day 237, Day 422 | |
| Secondary | Number of Participants Who Seroconverted Against D614G for Arms 2C-H | Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against D614G. Arms 2C and 2G Day 43 samples were used for pseudovirus neutralization assay validation and results included for completeness. Samples for other vaccination groups at Day 43 were not tested for neutralization. | Day 29, Day 43, Day 57, Day 119, Day 209, Day 394 | |
| Secondary | Number of Participants Who Seroconverted Against B.1.351 for Arms 1A and 1B | Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.351. | Day 15, Day 29, Day 91, Day 181, Day 366 | |
| Secondary | Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2B | Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.351. | Day 29, Day 57, Day 85, Day 147, Day 237, Day 422 | |
| Secondary | Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-H | Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.351. Arms 2C and 2G Day 43 samples were used for pseudovirus neutralization assay validation and results included for completeness. Samples for other vaccination groups at Day 43 were not tested for neutralization. | Day 29, Day 43, Day 57, Day 119, Day 209, Day 394 |
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