Study to Evaluate the Efficacy of COVID19-0001-USR in Patients With Mild/or Moderate COVID-19 Infection in Outpatient
NCT ID: NCT04595136
Last Updated: 2021-05-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2020-11-02
2021-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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COVID19-0001-USR
Group 1 Patients with SARS-COV-2 (COVID19) positive test will receive Investigational Drug administer by nebulization ( COVID-19-0001-USR) Dosage: 3ml Frequency and Duration: Three times a day for 7 days
Drug COVID19-0001-USR
COVID19-0001-USR by nebulization for patients with mild and/or moderate SARS- COV-2
Normal Saline
Group 2 of patients with positive tests intervention SARS-COV-2 (COVID19) with placebo (i.e., normal saline 0.9% NS) plus standard baseline treatment for covid provided by Primary care provider ( Azithromycin, dexamethasone, and/or anticoagulants) Dosage: 3ml Frequency and Duration: Three times a day for 7 days
normal saline
0.9% NS via nebulization
Interventions
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Drug COVID19-0001-USR
COVID19-0001-USR by nebulization for patients with mild and/or moderate SARS- COV-2
normal saline
0.9% NS via nebulization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Positive cases of COVID-19 (based on polymerase chain reaction or positive antigen test for SARS-CoV-2),
* Being diagnosed with mild to moderate SARS-COV-2 disease (COVID19)
* Symptomatic or asymptomatic patient, with good clinical appearance, Sat O2 at rest \> 94% with room air, and without desaturation with ambulation, and without tachypnea,
* Respiratory rate \< 20.
* Suspected cases of COVID-19, based on 3 criteria:
* Fever \> 38 Degrees Celsius
* O2 saturation ≤94
* Abnormal laboratory indicators, any of them:
* Lymphopenia \<1500 cells/m3
* C reactive protein \>2 mg/L
* Ferritin \>300g/L
Exclusion Criteria
* Respiratory Frequency \> 20 / min, Pulse \> 120 bpm, systolic \< 90 mmHg, diastolic \< 60 mmHg
* The patient seems toxic and distressed, or, O2 at rest \<93% in ambient air, or desaturation when ambulating
* Being diagnosed with severe SARS-COV-2 disease (COVID19)
* Patients with low oxygen saturation levels, need for ICU entry, need or likelihood of invasive mechanical ventilation
* Patients requiring bronchodilator treatment
* Patients with a known history of asthma and/or lung disease
* Patients with severe decompensated Chronic Obstructive Pulmonary Disease
* Patients who are unable to give consent or who are unable to follow up on the test group will be excluded
18 Years
ALL
No
Sponsors
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United Medical Specialties
OTHER
Responsible Party
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JUAN J JALLER-RAD
Principal Investigator
Principal Investigators
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Juan Jaller, MD
Role: PRINCIPAL_INVESTIGATOR
United Medical Specialties
Carlos A Riveros, MD
Role: STUDY_DIRECTOR
United Medical Specialties
Locations
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Cimedical
Barranquilla, Atlántico, Colombia
Countries
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Central Contacts
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Facility Contacts
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References
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Pena-Silva R, Duffull SB, Steer AC, Jaramillo-Rincon SX, Gwee A, Zhu X. Pharmacokinetic considerations on the repurposing of ivermectin for treatment of COVID-19. Br J Clin Pharmacol. 2021 Mar;87(3):1589-1590. doi: 10.1111/bcp.14476. Epub 2020 Jul 17. No abstract available.
Chan JF, Yip CC, To KK, Tang TH, Wong SC, Leung KH, Fung AY, Ng AC, Zou Z, Tsoi HW, Choi GK, Tam AR, Cheng VC, Chan KH, Tsang OT, Yuen KY. Improved Molecular Diagnosis of COVID-19 by the Novel, Highly Sensitive and Specific COVID-19-RdRp/Hel Real-Time Reverse Transcription-PCR Assay Validated In Vitro and with Clinical Specimens. J Clin Microbiol. 2020 Apr 23;58(5):e00310-20. doi: 10.1128/JCM.00310-20. Print 2020 Apr 23.
Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z, Yu J, Kang M, Song Y, Xia J, Guo Q, Song T, He J, Yen HL, Peiris M, Wu J. SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. N Engl J Med. 2020 Mar 19;382(12):1177-1179. doi: 10.1056/NEJMc2001737. Epub 2020 Feb 19. No abstract available.
Zheng S, Fan J, Yu F, Feng B, Lou B, Zou Q, Xie G, Lin S, Wang R, Yang X, Chen W, Wang Q, Zhang D, Liu Y, Gong R, Ma Z, Lu S, Xiao Y, Gu Y, Zhang J, Yao H, Xu K, Lu X, Wei G, Zhou J, Fang Q, Cai H, Qiu Y, Sheng J, Chen Y, Liang T. Viral load dynamics and disease severity in patients infected with SARS-CoV-2 in Zhejiang province, China, January-March 2020: retrospective cohort study. BMJ. 2020 Apr 21;369:m1443. doi: 10.1136/bmj.m1443.
Mitja O, Clotet B. Use of antiviral drugs to reduce COVID-19 transmission. Lancet Glob Health. 2020 May;8(5):e639-e640. doi: 10.1016/S2214-109X(20)30114-5. Epub 2020 Mar 19. No abstract available.
Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, Wang X, Yuan J, Li T, Li J, Qian S, Hong C, Wang F, Liu Y, Wang Z, He Q, Li Z, He B, Zhang T, Fu Y, Ge S, Liu L, Zhang J, Xia N, Zhang Z. Antibody Responses to SARS-CoV-2 in Patients With Novel Coronavirus Disease 2019. Clin Infect Dis. 2020 Nov 19;71(16):2027-2034. doi: 10.1093/cid/ciaa344.
Wagstaff KM, Sivakumaran H, Heaton SM, Harrich D, Jans DA. Ivermectin is a specific inhibitor of importin alpha/beta-mediated nuclear import able to inhibit replication of HIV-1 and dengue virus. Biochem J. 2012 May 1;443(3):851-6. doi: 10.1042/BJ20120150.
Mastrangelo E, Pezzullo M, De Burghgraeve T, Kaptein S, Pastorino B, Dallmeier K, de Lamballerie X, Neyts J, Hanson AM, Frick DN, Bolognesi M, Milani M. Ivermectin is a potent inhibitor of flavivirus replication specifically targeting NS3 helicase activity: new prospects for an old drug. J Antimicrob Chemother. 2012 Aug;67(8):1884-94. doi: 10.1093/jac/dks147. Epub 2012 Apr 25.
Yang SNY, Atkinson SC, Wang C, Lee A, Bogoyevitch MA, Borg NA, Jans DA. The broad spectrum antiviral ivermectin targets the host nuclear transport importin alpha/beta1 heterodimer. Antiviral Res. 2020 May;177:104760. doi: 10.1016/j.antiviral.2020.104760. Epub 2020 Mar 3.
Related Links
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Nebulized ivermectin for COVID-19 and other respiratory diseases, a proof of concept, dose-ranging study in rats
Other Identifiers
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COVID19-0001-USR
Identifier Type: -
Identifier Source: org_study_id
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