v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | NCT05135624 |
|
Full text link
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
rnn3b@virginia.edu |
|
Registration date
Last imported at : Nov. 30, 2021, 11 p.m. Source : ClinicalTrials.gov |
2021-11-26 |
|
Recruitment status
Last imported at : Dec. 19, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Recruiting |
|
Study design
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Sequential assignment |
|
Masking
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: to be considered eligible to participate in this study, the subject must meet all of the inclusion criteria listed below: hospitalized patients age ≥ 18 with diagnosis of sars-cov-2-infection based on positive pcr test result and can provide informed consent diagnosed with pneumonia due to sars-cov-2 respiratory rate ≥ 25/minute and spo2 ≤ 93% review of chest radiograph, chest computed tomography (ct) scan, or chest ultrasound consistent with bilateral infiltrates. horowitz index (partial pressure of oxygen/fraction of inspired oxygen [pao2/fio2]) ≤ 300. if a subject does not have an arterial line in place, a spo2/fio2 ≤ 315 may be used. |
|
Exclusion criteria
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
to be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below: age < 18 pregnant or lactating women history of heart failure clinically significant cardiac dysrhythmia, as determined by investigator history renal impairment presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (anc) less than 2000 mm3, aspartate aminotransferase |
|
Number of arms
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
3 |
|
Funding
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Serpin Pharma, LLC |
|
Inclusion age min
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Dec. 19, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
United States |
|
Type of patients
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Severe disease at enrollment |
|
Severity scale
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
6: Severe disease at enrollment |
|
Total sample size
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
20 |
|
primary outcome
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Change in acute phase reactants;Change in inflammatory cytokines;Safety and tolerability of SP16 in subjects with pneumonia due to SARS-CoV-2 |
|
Notes
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Phase 1/Phase 2 |
|
Arms
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "6 mg", "treatment_id": 2071, "treatment_name": "Sp16", "treatment_type": "Anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "12 mg", "treatment_id": 2071, "treatment_name": "Sp16", "treatment_type": "Anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |