CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 98 enrolled
Drug / intervention
GRAd-COV2biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04528641
NCT04528641Phase 1Completed
CompareCT.gov

A Phase 1, Dosage-Escalation Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine GRAd-COV2 in Healthy Adults and Elderly Subjects

ReiThera Srl·interventional·Posted Aug 27, 2020·Updated Feb 8, 2022

In Brief

A Phase 1 clinical trial evaluating GRAd-COV2 for COVID-19. Completed, enrolled 98 participants across 2 sites.

Detailed Summary

RT-CoV-2 is a Phase I, open-label, dose escalation multicenter clinical trial to assess safety and immunogenicity of the candidate Coronavirus disease (COVID-19) vaccine GRAd-COV2 in Italian healthy volunteers aged 18-55 years and 65-85 years inclusive. GRAd-COV2 is based on a novel replication defective Gorilla Adenovirus and encodes for SARS-COV-2 Spike protein.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesItaly
CollaboratorsIstituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedAug 27, 2020
Enrollment StartAug 10, 2020
Primary CompletionMay 19, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.8 years ago

Interventions

GRAd-COV2biological

Single intramuscular administration.