Trials Sponsors Conditions Drugs Pricing

Conditions

Pathogen Infection Covid-19 Infection

Keywords

Lentiviral vectorLV-DC vaccineCovid-19 CTL

Outcome Measures

Primary Outcomes (2)

Clinical improvement based on the 7-point scale
A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
28 days after randomization
Lower Murray lung injury score
Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.
7 days after randomization

Secondary Outcomes (8)

28-day mortality
Measured from Day 0 through Day 28
Duration of mechanical ventilation
Measured from Day 0 through Day 28
Duration of hospitalization
Measured from Day 0 through Day 28
Proportion of patients with negative RT-PCR results
7 and 14 days after randomization
Proportion of patients in each category of the 7-point scale
7,14 and 28 days after randomization
+3 more secondary outcomes

Study Arms (1)

pathogen-specific DC and CTLs

EXPERIMENTAL

Patients will receive approximately 5x10\^6 LV-DC vaccine and 1x10\^8 CTLs via sub-cutaneous injections and iv infusions, respectively.

Biological: Injection and infusion of LV-SMENP-DC vaccine and antigen-specific CTLs

Interventions

Injection and infusion of LV-SMENP-DC vaccine and antigen-specific CTLsBiological

Patients will receive approximately 5x10\^6 LV-DC vaccine and 1x10\^8 CTLs via sub-cutaneous injections and iv infusions, respectively.

pathogen-specific DC and CTLs

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age6 Months - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Laboratory (RT-PCR) confirmed Covid-19 infection in throat swab and/or sputum and/or lower respiratory tract samples;
The interval between the onset of symptoms and randomized is within 7 days. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used;

Sponsors & Collaborators

Shenzhen Geno-Immune Medical Institute
Otherlead

Study Sites (1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

Lung-Ji Chang, PhD
Shenzhen Geno-Immune Medical Institute
PRINCIPAL INVESTIGATOR

Enrollment

100 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 19, 2020

Study Start

June 1, 2026

Actual (reported)

Immunity and Safety of Covid-19 Synthetic Minigene Vaccine

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (1)

pathogen-specific DC and CTLs

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (1)

pathogen-specific DC and CTLs

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations