A Phase III Randomized, Double Blind, Placebo-controlled,

Multicenter Study to Determine the Safety and Efficacy of

ABC1234 for the Treatment of COVID-19 in Non-hospitalized

Adults between 40-70 years old

 Brief Description

 COVID-19's serious outbreak and the precipitously increasing mortality rate across the globe

necessitated the urgent need to develop an effective ABC1234 vaccine.

 COVID-19's severity depends on the patient's age, with severe cases of the illness

characterized by lung injury and Acute Respiratory Distress.

 Phase III is a randomized, double-blind, placebo-controlled multicenter study to examine the

effectiveness of the ABC1234 vaccine in 30 non-hospitalized adults between 40-70 years old.

 Each participant who qualifies to participate will receive a placebo or doses of ABC1234 up to

the target dose.

 Mobilisation Plan

 Mobilisation approach

 To mobilise UK multi-centres on time, on budget and meeting all criteria that a top healthcare

facility demands.

 To understand the complexities in coordinating participants and staff and the critical risks that

should be considered to achieve a successful mobilisation.

 The focus of this case study will concentrate on comprehensive planning, risk management,

progress monitoring and effective resourcing.

 This way, the multicenter will receive the most efficient, cost-effective establishment of services

with the lowest risk factor.

 Mobilisation Plan Continuation
 Study setting: The approved case study protocols and related materials, including consent forms, case

report forms and study kits, will be submitted to 15 participating multi-centres.  

 All study centers are located in the UK

 Participants: Participants will include non-hospitalized individuals between 40-70 years.

 Pregnant women or breastfeeding will be disqualified from this case study.

 Participants will only be included in the case study after signing the consent form and undergoing

screening evaluation to meet the inclusion and exclusion criteria

 Randomization: There will be two randomization lists based on the vaccine or placebo at a 1: 1 ratio. 
 Staff Requirement

 Clinical care team

 Research team

 Data analysts and data management personnel

 Outcome assessors
 Study Design

 Type of study: Case study (clinical trial)-

 This case study clinical trial will be used to generate in-depth understanding of the safety and

efficacy of ABC1234 vaccine.

 The case study will help researchers to collect information on more descriptive how, what and

why questions.

 For instance, in this case study, the research will ask questions such as how are the researchers

implementing the intervention and how is the intervention being received on the ground

 Actual enrolment: 30 participants

 Study Design

 Allocation of Participants: Randomisation

 Participants will be assigned by chance to different treatment groups the treatment and

placebo.

 The placebo is does not contain any active components but will have a physical effects on the

participants allocated to the group.

 Intervention Model: Parallel Assignment

 Participants assigned to the treatment and placebo groups at the beginning of the clinical trial

will continue with that group throughout the length of the trial
 Study Design Continuation
 Masking: Double Blind

 Neither the participants nor the researchers know the treatment or intervention participants are

receiving until the clinical trial comes to an end.

 For this reason, the results are less likely to be affected by factors that are not linked to the

treatment being tested.

 Primary Purpose- Treatment

 Official Title: A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter Study to

Determine the Safety and Efficacy of ABC1234 for the Treatment of COVID-19 in Non-hospitalized

Adults between 40-70 years old

 Study Design Continuation

 Intervention and Group

 Experimental: ABC1234-upto about 30 participants will be randomized in a ratio of 1:1.

Group 1: (n= up to approximately 15 participants) will receive the targeted dose of ABC1234.

 Placebo Comparator

 Up to approximately 30 participants will be randomized in a ratio of 1:1. Group 2 (n=up to

approximately 15 participants will receive the targeted dose of placebo.

 Patient Identification

 Ages qualified for the study: 40 to 70 years

 Sexes eligible for study: All

 Accepts non- hospitalised participants

 Inclusion criteria

 Participants have acknowledged laboratory established SARS-COV-2 infection ascertained by a

molecular test from any respiratory tract specimen.

 Male or female 40 to 70 years of age.

 If female of child bearing age has negative serum pregnancy test.

 Patient Identification
 Exclusion Criteria

 Received convalescent COVID-19 plasma treatment any time prior to entry into this case

study.

 Pregnant or breastfeeding women.

 Participants with chronic illnesses or conditions that may upsurge the risk to the participants

that may adversely affect their ability to contribute to this study.

 Adverse reaction to any monoclonal antibodies or identified allergies to components of

placebo.
 Patient Identification Sites

 Participant Identification Centers (PICs) should be NHS/HSC organisations that identify

prospective research participants. They are not research sites and should not be treated in a similar

manner as research sites.

 The PIC centers should identify potential case study participants by processing their personal data

by performing search of patient records to identify their eligibility criteria.

 PIC sites should follow the sponsor’s instructions in finding prospective research participants.

 PIC sites should direct prospective participants to a different place without handling any further

activity for the case study.

 Review, Sponsor Meetings and Reporting

 Review

 The sponsors should present an Investigational New Drug (IND) application to Food and Drug

Administration (FDA) before the commencement of the clinical study.

 The IND investigation must include toxicity and side effects data that cause great harm

 Manufacturing information

 Clinical protocol for the case study

 Information about the investigator

 Data from any human research conducted before this case study
Review, Sponsor Meetings and Reporting Continuation

 The review team consists of specialists from diverse fields each with different responsibilities.

 Project manager: Is the sponsor’s primary contact and coordinates the activities of the team all

through the review process

 Medical officer: Reviews the case study data before during and after the case study.

 Statistician: Interprets data from the clinical trial.

 Pharmakineticist: Assesses drug dosages and administration dosages.

 Chemist: Evaluates the chemical compounds of ABC1234 vaccine.

 Review, Sponsor Meetings and Reporting Continuation
Meetings

 The FDA review team has 30 days to analyze the original IND submission. The process is crucial in

protecting participants from perverse and significant risk in the clinical trials.

 FDA acknowledges IND applications in one of these ways:

 Authorising the team to commence clinical trials.

 Clinical hold to postpone or discontinue the case study.

 A clinical hold by FDA results from :

 Subjection of participants to biasness or noteworthy risk.

 Unqualified Investigators.

 Misleading materials for volunteers

 Insufficient information from the IND about the risks of the clinical trial.
Review, Sponsor Meetings and Reporting Continuation
 Reporting : The review team should be informed about the new protocols and adverse side effects of

the trial to ensure careful monitoring of the trials for signs of significant risks and problems.

 Researchers should submit case study reports after the clinical trial.

 Sponsors must report the information below for evaluation:

 Unanticipated and severe adverse reactions due to the administered medication during the

clinical practice.

 Serious breaches that significantly affect the safety and rights of participants and reliability of

generated data.

 Measures taken to protect the study participants due to unanticipated events that might affect

the risk balance of the case study.