NCT04407182

Brief Summary

This is a two-arm, open-label, randomized, phase 2, controlled center study to assess the safety and efficacy of Viusid and Asbrip in patients with mild to moderate symptoms of respiratory disease caused by 2019 coronavirus infection. Patients will be randomized to receive daily doses of 30 ml of Viusid and 10 ml of Asbrip every 8 hours or standard care. Viusid and Asbrip will be administered orally. A total of 60 subjects will be randomized 2: 1 in this study. 40 patients will be assigned to Viusid plus Asbrip plus standard of care and 20 control patients with standard of care. Treatment duration: 21 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 covid19

Timeline
Completed

Started May 2020

Shorter than P25 for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

January 8, 2021

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

May 25, 2020

Last Update Submit

January 7, 2021

Conditions

Covid-19Sars-CoV2Diabete MellitusCardiopathyPulmonary DiseaseRenal DiseaseLiver Diseases

Keywords

Covid-19SARS-CoV2Immuno-modulatorantioxidantnutritional supplement

Outcome Measures

Primary Outcomes (1)

  • Symptom resolution

    The number of days required to achieve a score of 0 for each symptom category. 1. Resolution of symptoms: fever (time frame: 21 days) Fever based on a 0-3 scale: 0 = ≤98.6, 1 =\> 98.6- 100.6, 2 =\> 100.6 - 102.6, 3 =\> 102.6 2. Resolution of symptoms: cough (time frame: 21 days) Cough based on a 0-3 scale: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe 3. Resolution of symptoms: shortness of breath (time frame: 21 days) Shortness of breath based on a 0-3 scale: 0 = no shortness of breath, 1 = with moderate intensity exercise 2 = walking on a flat surface 3 = shortness of breath when dressing or doing daily activities 4. Resolution of symptoms: fatigue (period: 21 days) Fatigue based on a 0-3 scale: 1 = mild fatigue, 2 = moderate fatigue, 3 = severe fatigue. 5. Composite score that includes all symptoms: (time frame: 21 days) Total composite score of symptoms on days 5, 10, 15, and 21 of study supplementation.

    21 days

Secondary Outcomes (13)

  • Cumulative incidence of disease severity

    21 days

  • Complementary drugs required

    21 days

  • Side effects of supplementation

    21 days

  • Duration of SARS-CoV-2 PCR positivity

    21 days

  • Concentration of reactive protein c in peripheral blood

    21 days

  • +8 more secondary outcomes

Other Outcomes (14)

  • Change from baseline in serum cytokine levels

    21 days

  • Change from baseline in serum cytokine levels

    21 days

  • Change from baseline in serum cytokine levels

    21 days

  • +11 more other outcomes

Study Arms (2)

Viusid Plus Asbrip

EXPERIMENTAL

Patients will be randomized to receive daily doses of 30 ml of Viusid and 10 ml of Asbrip every 8 hours or standard care. Viusid and Asbrip will be administered orally. A total of 60 subjects will be randomized 2: 1 in this study. 40 patients will be assigned to Viusid plus Asbrip plus standard of care. Treatment duration: 21 days.

Dietary Supplement: Viusid and Asbrip

Control

NO INTERVENTION

A total of 60 subjects will be randomized 2: 1 in this study. 20 Control patients will be assigned to standard of care. Treatment duration: 21 days.

Interventions

Viusid and AsbripDIETARY_SUPPLEMENT

Patients will be randomized to receive daily doses of 30 ml of Viusid and 10 ml of Asbrip every 8 hours plus standard care. Viusid and Asbrip will be administered orally. Treatment duration: 21 days.

Viusid Plus Asbrip

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Population over 18 years of age up to 70, sample size 30.
  • Subjects with mild to moderate\* symptoms of respiratory illness caused by 2019 coronavirus infection as defined below: Mild disease (uncomplicated):
  • Diagnosed with COVID-19 by a standardized RT-PCR assay and Mild symptoms, such as fever, runny nose, mild cough, sore throat, malaise, headache, muscle pain, or discomfort, but no shortness of breath and No signs of more serious lower airway disease.
  • RR \<20, HR \<90, oxygen saturation (pulse oximetry)\> 93% in ambient air.
  • \*Moderate illness:
  • Diagnosed with COVID-19 by a standardized RT-PCR assay and
  • In addition to the above symptoms, more significant lower respiratory symptoms, including difficulty breathing (at rest or with exertion) or
  • Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry)\> 93% in ambient air, and
  • If available, X-ray or computed tomography-based lung infiltrates \<50% present 3. 12-lead ECG at rest clinically normal at the screening visit or, if abnormal, not considered clinically significant by the lead investigator.
  • \. The subject (or legally authorized representative) provides her informed written consent before starting any study procedure.
  • \. Understand and agree to comply with planned study procedures. 6. Women of childbearing potential must agree to use at least one medically accepted method of contraception (eg, barrier contraceptives \[condom or diaphragm with a spermicidal gel\], hormonal contraceptives \[implants, injectables, combined oral contraceptives, transdermal patches or rings) \] or intrauterine devices) for the duration of the study.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Especialidades Dr. Teodoro Maldonado Carbo

Guayaquil, 090510, Ecuador

Location

Related Publications (8)

  • Hui DS, I Azhar E, Madani TA, Ntoumi F, Kock R, Dar O, Ippolito G, Mchugh TD, Memish ZA, Drosten C, Zumla A, Petersen E. The continuing 2019-nCoV epidemic threat of novel coronaviruses to global health - The latest 2019 novel coronavirus outbreak in Wuhan, China. Int J Infect Dis. 2020 Feb;91:264-266. doi: 10.1016/j.ijid.2020.01.009. Epub 2020 Jan 14. No abstract available.

    PMID: 31953166BACKGROUND

  • Lu R, Zhao X, Li J, Niu P, Yang B, Wu H, Wang W, Song H, Huang B, Zhu N, Bi Y, Ma X, Zhan F, Wang L, Hu T, Zhou H, Hu Z, Zhou W, Zhao L, Chen J, Meng Y, Wang J, Lin Y, Yuan J, Xie Z, Ma J, Liu WJ, Wang D, Xu W, Holmes EC, Gao GF, Wu G, Chen W, Shi W, Tan W. Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. Lancet. 2020 Feb 22;395(10224):565-574. doi: 10.1016/S0140-6736(20)30251-8. Epub 2020 Jan 30.

    PMID: 32007145BACKGROUND

  • Yang J, Zheng Y, Gou X, Pu K, Chen Z, Guo Q, Ji R, Wang H, Wang Y, Zhou Y. Prevalence of comorbidities and its effects in patients infected with SARS-CoV-2: a systematic review and meta-analysis. Int J Infect Dis. 2020 May;94:91-95. doi: 10.1016/j.ijid.2020.03.017. Epub 2020 Mar 12.

    PMID: 32173574BACKGROUND

  • Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26.

    PMID: 32113704BACKGROUND

  • Wu JT, Leung K, Leung GM. Nowcasting and forecasting the potential domestic and international spread of the 2019-nCoV outbreak originating in Wuhan, China: a modelling study. Lancet. 2020 Feb 29;395(10225):689-697. doi: 10.1016/S0140-6736(20)30260-9. Epub 2020 Jan 31.

    PMID: 32014114BACKGROUND

  • Spina S, Marrazzo F, Migliari M, Stucchi R, Sforza A, Fumagalli R. The response of Milan's Emergency Medical System to the COVID-19 outbreak in Italy. Lancet. 2020 Mar 14;395(10227):e49-e50. doi: 10.1016/S0140-6736(20)30493-1. Epub 2020 Feb 28. No abstract available.

    PMID: 32119824BACKGROUND

  • Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.

    PMID: 32192578BACKGROUND

  • Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.

    PMID: 32125452BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19Diabetes MellitusHeart DiseasesLung DiseasesKidney DiseasesLiver Diseases

Interventions

Viusid

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsRespiratory Tract DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCardiovascular DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2020

First Posted

May 29, 2020

Study Start

May 4, 2020

Primary Completion

August 1, 2020

Study Completion

October 1, 2020

Last Updated

January 8, 2021

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations

EC(1)