Covid 19 Clinical Trials

	Name (Synonyms)	Correlation
D011024	Pneumonia, Viral NIH	0.14
D055371	Acute Lung Injury NIH	0.13
D012127	Respiratory Distress Syndrome, Newborn NIH	0.13
D012128	Respiratory Distress Syndrome, Adult NIH	0.11
D045169	Severe Acute Respiratory Syndrome NIH	0.06
D018352	Coronavirus Infections NIH	0.05

Correlated HPO Terms (0)

	Name (Synonyms)	Correlation

There is one clinical trial.

Clinical Trials

1 Phase I, Double-Blinded, Placebo-Controlled, Dose- Escalation Study of the Safety and Immunogenicity of Recombinant SARS-CoV deltaTM S Protein Vaccine Formulated With and Without Alhydrogel® in Healthy Adults When Administered by the Intramuscular Route

This is a multi-center, randomized, double-blinded, placebo-controlled, outpatient study. Recombinant deltaTM S Protein Severe Acute Respiratory Syndrome (SARS) Vaccine With and Without Aluminum Hydroxide Adjuvant (Provided through contract N01-AI-30023, manufactured by Protein Sciences Corporation), two doses, administered at 28 day interval. 1. S Protein Severe Acute Respiratory Syndrome (SARS) Vaccine without adjuvant: 5.0, 15.0 and 45.0 mcg per 0.5 ml dose. 2. S Protein SARS Adjuvanted Vaccine: 5.0, 15.0 and 45.0 mcg per 0.5 ml dose. PLACEBO: diluents/placebo without vaccine (Phosphate Buffer Saline (PBS) with lower phosphate concentration). Approximately 84 healthy male and nonpregnant female subjects 18 to 40 years of age will be enrolled.

NCT01376765 SARS Drug: Aluminum hydroxide adjuvant (Alhydrogel®) Other: Phosphate buffered saline Placebo Biological: Recombinant S protein SARS vaccine

Primary Outcomes

Measure: Occurrence of solicited local and systemic adverse events (AE)within 8 days after vaccination (Days 0-7 and Days 28-35)

Time: 8 days after vaccination (Days 0-7 and Days 28-35)

Measure: Incidence of vaccine-related serious adverse events (SAEs) throughout the duration of the study.

Time: Day 0 to Day 758

Measure: Occurrence of laboratory abnormalities at 8 days after vaccination (Days 8 and 36)

Time: 8 days after vaccination (Days 8 and 36)

Secondary Outcomes

Measure: Immunogenicity: Proportion of subjects achieving a detectable serum neutralizing antibody titer against SARS-CoV in each immunized group 28 days after receipt of the second dose of vaccine (approximately Day 56)

Time: 28 days after receipt of the second dose of vaccine (approximately Day 56)

Measure: Immunogenicity: GMT of neutralizing antibody titers against SARS-CoV in each immunized group 28 days after receipt of the second dose of vaccine (Day 56). Measurement will include the Day 56 GMT and the mean fold change (GMT ratio Day 56:Day 0)

Time: 28 days after receipt of the second dose of vaccine (Day 56)

Measure: Comparison of rates of unsolicited AEs related to vaccine for all subjects between treatment groups and in the combined cohorts receiving vaccine with aluminum hydroxide adjuvant compared with those receiving vaccine with no adjuvant.

Time: intervals from Days 0-7, Days 0-28, Days 8-28, Days 0-56, Days 29-36, and Days 29-56.

Measure: Immunogenicity: Geometric Mean Titer (GMT) of antibody titers (IgG ELISA for S protein of SARS-CoV) 28 days after receipt of the second dose of vaccine (Day 56) at each vaccine dose level, with and without adjuvant

Time: 28 days after receipt of the second dose of vaccine (Day 56)

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation

Correlated Drug Terms (3)